Acellular dermal regenerative tissue matrix for diabetic foot ulcers

NewsBot · Aug 6, 2008

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A multicenter study involving the use of a human acellular dermal regenerative tissue matrix for the treatment of diabetic lower extremity wounds.
Winters CL, Brigido SA, Liden BA, Simmons M, Hartman JF, Wright ML.
Adv Skin Wound Care. 2008 Aug;21(8):375-81

This multicenter, retrospective study presents the use of a human acellular dermal regenerative tissue matrix as an alternative treatment for 100 chronic, full-thickness wounds of the lower extremity in 75 diabetic patients. Comorbidities included cardiac disease (86.0%), neuropathy (86.0%), peripheral vascular disease (82.0%), infection (54.0%), obesity (51.0%), and osteomyelitis (37.0%). Wound locations included the foot (86.0%), ankle (8.0%), and lower extremity (6.0%). Mean wound age was 20.4 weeks (1.3-191.4 weeks). University of Texas (UT) wound classifications included 15 (15.0%) 1A, 1 (1.0%) 1B, 1 (1.0%) 1C, 2 (2.0%) 1D, 18 (18.0%) 2A, 8 (8.0%) 2B, 5 (5.0%) 2C, 3 (3.0%) 2D, 3 (3.0%) 3A, 7 (7.0%) 3B, 3 (3.0%) 3C, and 34 (34.0%) 3D. The mean time to matrix incorporation, 100% granulation, and complete healing was 1.5 weeks (0.43-4.4 weeks), 5.1 weeks (0.43-16.7 weeks), and 13.8 weeks (1.7-57.8 weeks), respectively. The overall matrix success rate, as defined by full epithelialization, was 90.0%. One failed wound subsequently healed approximately 7 weeks after matrix reapplication. The healing rate was 91.0%, as 91 of the 100 wounds healed. No statistically significant differences were observed between UT classifications and time to matrix incorporation, 100% granulation, and complete healing. Absence of matrix-related complications and high rates of closure in a wide array of diabetic wounds suggest that this matrix is a viable treatment for complex lower extremity wounds. Lack of any statistically significant differences between UT grades and wound outcome end points lends further support to the universal applicability of this matrix, with successful results in both superficial diabetic wounds and in wounds penetrating to the bone or joint.
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NewsBot · Jun 20, 2012

Acellular Fetal Bovine Dermal Matrix for Treatment of Chronic Ulcerations of the Midfoot Associated With Charcot Neuroarthropathy
Steven J. Kavros
Foot Ankle Spec June 19, 2012

Background. Gross deformity of the foot in Charcot neuroarthropathy can lead to collapse and subsequent ulceration, infection, amputation, or premature death. This study evaluated healing of midfoot ulcerations of Charcot neuroarthropathy using PriMatrix, a novel acellular fetal bovine dermal matrix.

Methods. In this retrospective analysis, 20 patients with ulcerations of the midfoot associated with Charcot neuroarthropathy were treated with either PriMatrix in addition to standard wound care (PriMatrix group,n = 12) or standard wound care alone (control group, n = 8). All patients had chronic, nonhealing foot ulcerations of at least 2250 mm3 for a minimum of 30 days duration. All foot ulcerations were full thickness with subcutaneous involvement. Ankle brachial index ≥0.90 and/or transcutaneous oximetry (TcPo2) ≥40 mm Hg at the periulcer site was necessary for inclusion. Patients were excluded if they had acute or chronic osteomyelitis of the foot.

Results. Demography, risk factors, baseline severity of Charcot neuroarthropathy, and wound volume (control 4078 mm3, PriMatrix 3737.5 mm3, P = nonsignificant) were similar between treatment groups. Mean time to healing in the PriMatrix group (116 days, 95% CI = 109-123) was significantly shorter than in the control group (180 days, 95% confidence interval [CI] = 171-188); P < .0001. A significantly faster rate of healing was observed with PriMatrix (87.9 mm3/wk, 95% CI = 115.2% to 60.6%) compared with control (59.0 mm3/wk, 95% CI = 72.8% to 45.3%); P < .0001).

Conclusions. The significantly faster rate of healing and steeper slope of volume reduction in the PriMatrix group warrants further investigation into its effects on healing of neuropathic ulcerations and potential limb salvage.
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NewsBot · Jul 18, 2014

The Use of PriMatrix, a Fetal Bovine Acellular Dermal Matrix, in Healing Chronic Diabetic Foot Ulcers: A Prospective Multicenter Study.
Kavros SJ, Dutra T, Gonzalez-Cruz R, Liden B, Marcus B, McGuire J, Nazario-Guirau L.
Adv Skin Wound Care. 2014 Aug;27(8):

OBJECTIVE::
The objective of this multicenter study was to prospectively evaluate the healing outcomes of chronic diabetic foot ulcers (DFUs) treated with PriMatrix (TEI Biosciences, Boston, Massachusetts), a fetal bovine acellular dermal matrix.
METHODS::
Inclusion criteria required the subjects to have a chronic DFU that ranged in area from 1 to 20 cm and failed to heal more than 30% during a 2-week screening period when treated with moist wound therapy. For qualifying subjects, PriMatrix was secured into a clean, sharply debrided wound; dressings were applied to maintain a moist wound environment, and the DFU was pressure off-loaded. Wound area measurements were taken weekly for up to 12 weeks, and PriMatrix was reapplied at the discretion of the treating physician.
RESULTS::
A total of 55 subjects were enrolled at 9 US centers with 46 subjects progressing to study completion. Ulcers had been in existence for an average of 286 days, and initial mean ulcer area was 4.34 cm. Of the subjects completing the study, 76% healed by 12 weeks with a mean time to healing of 53.1 ± 21.9 days. The mean number of applications for these healed wounds was 2.0 ± 1.4, with 59.1% healing with a single application of PriMatrix and 22.9% healing with 2 applications. For subjects not healed by 12 weeks, the average wound area reduction was 71.4%.
CONCLUSION::
The results of this multicenter prospective study demonstrate that the use of PriMatrix integrated with standard-of-care therapy is a successful treatment regimen to heal DFUs.
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NewsBot · Jan 5, 2017

This clinical trial was just registered:
PriMatrix for the Management of Diabetic Foot Ulcers

The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the management of diabetic foot ulcers in subjects with diabetes mellitus versus the Standard of Care treatment. Half of patients will be treated using PriMatrix while the other half will receive Standard of Care treatment.
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NewsBot · Feb 27, 2017

Efficacy and safety of acellular dermal matrix in diabetic foot ulcer treatment: A systematic review and meta-analysis.
Guo X et al
Int J Surg. 2017 Feb 14;40:1-7. doi: 10.1016/j.ijsu.2017.02.008.

BACKGROUND:
Diabetic foot ulcer(DFU) is a chronic, refractory disease in need of multidisciplinary endeavour, miscellaneous strategies have been adopted to address this annoying issue, including acellular dermal matrix(ADM)/negative pressure wound therapy/standard of care (SOC) etc. However, consensus has not been reached. As a promising procedure, the efficacy and safety of ADM remains controversial. We therefore performed a meta-analysis of randomized controlled trials (RCTs) to compare the efficacy and safety of acellular dermal matrix to standard of care in DFU.
METHODS:
Databases, including Pubmed, Medline, Embase and Cochrane library were searched to identify RCTs comparing ADM to SOC in DFU patients. The outcomes mainly included complete wound healing, mean time to heal and adverse events.
RESULTS:
A total of 632 DFU patients from 6 RCTs were subjected to meta-analysis. The results showed that compared with the merely SOC, the complete healing rate in ADM group was higher both at 12 weeks [risk ratio (RR) 2.31, 95% confidence interval (CI) 1.42 to 3.76] and 16 weeks [RR 1.57, 95% CI 1.28 to 1.93]. The mean time to complete wound healing was shorter in ADM group [MD = -2.98, 95% CI: -5.15 to -0.82]. The occurrence of adverse event in both groups showed no significant difference [RR 0.98, 95%CI 0.58 to 1.67].
CONCLUSION:
Compared with standard of care, acellular dermal matrix may accelerate the healing velocity of uninfected, non-ischemic, full-thickness diabetic foot ulcer. Acellular dermal matrix showed superiority compared with standard of care alone, while generating no more complications.
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NewsBot · May 4, 2017

The Role of Dermal Matrices in Treating Inflammatory and Diabetic Wounds.
Climov M et al
Plast Reconstr Surg. 2016 Sep;138(3 Suppl):148S-57S.

BACKGROUND:
Dermal matrices are used to improve healing in both acute and chronic wounds including diabetic and lower extremity wounds, burns, trauma, and surgical reconstruction. The use of dermal matrices for the closure of inflammatory ulcerations is less frequent but growing. Currently available products include decellularized dermis and semisynthetic matrices.
METHODS:
A review of the published literature was performed to identify reports that use acellular dermal matrices in diabetic and inflammatory wounds. Studies were evaluated for quality and outcomes, and a level of evidence was assigned according to the American Society of Plastic Surgeons' Rating Levels of Evidence. Case studies from the authors' experience are also presented.
RESULTS:
Seventeen primary studies evaluating the use of dermal matrices in diabetic ulcers were identified with 2 based on level I data. There are no prospective clinical trial reports of their use in atypical or inflammatory wounds, but there are several case studies.
CONCLUSIONS:
Treatment of diabetic and inflammatory wounds may include both medical and surgical modalities. The use of dermal matrices can be a useful adjunct, but their optimal use will require future clinical studies.
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NewsBot · May 26, 2017

A Randomized Clinical Trial of a Human Acellular Dermal Matrix Demonstrated Superior Healing Rates for Chronic Diabetic Foot Ulcers over Conventional Care and an Active Acellular Dermal Matrix Comparator.
Cazzell S et al
Wound Repair Regen. 2017 May 24. doi: 10.1111/wrr.12551.

This study compared the efficacy and safety of a human acellular dermal matrix (ADM), D-ADM, with a conventional care arm and an active comparator human ADM arm, GJ-ADM, for the treatment of chronic diabetic foot ulcers. The study design was a prospective, randomized controlled trial that enrolled 168 diabetic foot ulcer subjects in 13 centers across 9 states. Subjects in the ADM arms received one application but could receive one additional application of ADM if deemed necessary. Screen failures and early withdrawals left 53 subjects in the D-ADM arm, 56 in the conventional care arm, and 23 in the GJ-ADM arm (2:2:1 ratio). Subjects were followed through 24 weeks with major endpoints at Weeks 12, 16, and 24. Single application D-ADM subjects showed significantly greater wound closure rates than conventional care at all three endpoints while all applications D-ADM displayed a significantly higher healing rate than conventional care at Week 16 and Week 24. GJ-ADM did not show a significantly greater healing rate over conventional care at any of these time points. A blinded, third party adjudicator analyzed healing at Week 12 and expressed 'strong' agreement (κ=0.837). Closed ulcers in the single application D-ADM arm remained healed at a significantly greater rate than the conventional care arm at 4 weeks post-termination (100% versus 86.7%; p= 0.0435). There was no significant difference between GJ-ADM and conventional care for healed wounds remaining closed. Single application D-ADM demonstrated significantly greater average percent wound area reduction than conventional care for Weeks 2-24 while single application GJ-ADM showed significantly greater wound area reduction over conventional care for Weeks 4-6, 9, and 11-12. D-ADM demonstrated significantly greater wound healing, larger wound area reduction, and a better capability of keeping healed wounds closed than conventional care in the treatment of chronic DFUs.
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NewsBot · Jun 10, 2017

Failure rates of artificial dermis products in treatment of diabetic foot ulcer: A systematic review and network meta-analysis.
Tchero H et al
Wound Repair Regen. 2017 Jun 8. doi: 10.1111/wrr.12554

Diabetic foot ulcer (DFU) is a frequent complication in diabetic patients, occurring in up to 25% of those affected. Among the treatments available to clinicians, the use of bioengineered skin substitutes is an attractive alternative. Artificial dermis functions as a matrix, covering the wound and supporting healing and reconstruction of the lost tissue. This study was aimed at reviewing the use of five regeneration matrices (namely, Integra, Nevelia, Matriderm, Pelnac and Renoskin) as reported by clinical trials. We searched Medline, Embase, ISI Web of Science, Scopus and Cochrane Central Register of Controlled Trials databases for relevant studies. Risk of failure rates was analysed by relative risk ratio method and complete ulcer healing was studied using network meta-analysis. Thirteen studies (12 RCTs and one cohort study) were eligible for analysis. The network meta-analysis based on a single study for Matriderm and 12 studies for other products showed that Matriderm was statistically inferior in achieving complete ulcer healing, as compared to all other products combined. In the second phase analysis, which was limited to three studies using artificial dermis products, there was a 57% reduction in the risk of re-epithelialization failure for DFU patients who used Matriderm or Pelnac, compared to those who used Pelnac with basic fibroblast growth factor spray or skin grafting. The data showed an overall low failure rate suggesting that these bioengineered skin products provide a suitable support and microenvironment for healing of DFUs with low ulcer recurrence rates. This systematic review with meta-analysis highlights the pressing need for more studies investigating the safety, efficacy and failure rates of regeneration matrices in the treatment of DFUs.
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NewsBot · Jun 11, 2017

The Comparative Effectiveness of a Human Fibroblast Dermal Substitute versus a Dehydrated Human Amnion/Chorion Membrane Allograft for the Treatment of Diabetic Foot Ulcers in a Real-world Setting.
Kraus I, Sabolinski ML, Skornicki M, Parsons NB.
Wounds. 2017 May;29(5):125-132.

BACKGROUND:
Impaired wound healing is associated with serious complications in patients with diabetes. Diabetic foot ulcers (DFUs) can lead to costly complications and an increased mortality rate. Standard treatments for DFUs often need to be augmented with adjunctive therapies designed to stimulate healing in recalcitrant wounds.
OBJECTIVE:
This analysis was conducted to evaluate the comparative effectiveness of a human broblast-derived dermal substitute (HFDS) and a dehydrated human amnion/chorion membrane allograft (dHACM) for the treatment of DFUs.
MATERIALS AND METHODS:
Using a wound care-specic electronic health record database, real-world outcomes from 122 patients with 122 DFUs receiving treatment in 2014 in 72 wound care facilities across the United States were evaluated. Key criteria for entry into the analysis included ulcer size ≥ 1 cm2 to < 25 cm2, ulcer duration ≤ 1 year, and ulcer area reduction ≤ 20% in the 14 days prior to the rst treatment. Key exclusion criteria included lack of follow-up visits and lack of baseline wound measurements. The frequency of wound closure by weeks 12 and 24, median time to wound closure, hazard ratio with 95% con dence interval, and P value were estimated from a Cox model with terms for treatment, baseline wound area, baseline wound duration, baseline wound depth, and wound location.
RESULTS:
The results show the incidence of wound closure for HFDS compared with dHACM was signicantly improved by weeks 12 (55% vs. 32%) and 24 (76% vs. 50%). The HFDS treatment signi cantly increased the probability of wound closure by 107%, with a median time to closure of 7.4 weeks (38%) less than that of dHACM treatment (P = .02).
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NewsBot · May 11, 2019

Cellular versus Acellular Matrix Devices in the Treatment of Diabetic Foot Ulcers: Interim Results of a Comparative Efficacy Randomized Controlled Trial.
Tchanque-Fossuo CN et al
J Tissue Eng Regen Med. 2019 May 9

Healing of diabetic foot ulcers (DFU) is a major challenge. Despite adhering to optimal standard of care (SOC), less than 30% of wounds heal after 20 weeks. Advanced cellular tissue-based products have shown better healing over SOC, albeit with great cost and modest improvement. We hypothesized no difference in healing effected by either cellular (Dermagraft), non-cellular (Oasis) devices, relative to SOC in treating DFU in a randomized controlled trial. The primary and secondary outcomes were the percentage of subjects that achieved complete wound closure by study endpoint (12 weeks of treatment) and study completion, respectively. During the 2-week screening phase with SOC, subjects with 40% change in ulcer size were excluded. After randomization, fifty-six patients entered an active treatment phase (8 weeks) followed by a maintenance phase (4 weeks SOC), with endpoint at visit 15, and 4 monthly follow-up visits. There was equal distribution of demographic data (p>0.05) and no difference in initial wound characteristics (p>0.05) between all groups. No differences were observed in complete wound closure by 12 and 28 weeks of treatment, nor were there any difference in percentage area reduction from treatment week 1 to 12, and from treatment week 1 to 28 between the groups. Each of the treatment arms showed statistically significant reduction in wound area from treatment week 1 to 28 (p<0.05). This exploratory analysis suggests that the outcomes of treatment with either Dermagraft or Oasis matrix are comparable. We have completed enrollment and the final data analysis is underway to make definitive conclusions.
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NewsBot · Jan 6, 2020

Clinical Efficacy of Acellular Dermal Matrix Paste in Treating Diabetic Foot Ulcers.
Lee M et al
Wounds. 2019 Dec 9

INTRODUCTION:
Diabetic foot ulcers (DFUs) are slow to heal because of poor tissue vascularity and regenerative capacity, among various factors.

OBJECTIVE:
In this study, the authors evaluate the efficacy of applying a paste formulation of acellular dermal matrix (ADM) to DFUs.

MATERIALS AND METHODS:
Patients with Wagner grade 2 or 3 DFUs (N = 49) received either ADM paste (treatment group; n = 23) or conventional foam dressing (control group; n = 26). All chronic wounds were debrided and irrigated in an attempt to control infection. After paste application, mild compaction was undergone to fill ulcer cavities, and foam dressings were used to cover the surface to absorb any discharge. All DFUs were analyzed with regard to ulcer area, depth, progression, healing rate, and duration to complete healing.

RESULTS:
At the 60-day primary outcome mark, 56.52% (13/23) of the DFUs in the treatment group were healed, compared with 23.08% (6/26) of DFUs in the control group. Mean rates of wound area resolution in the treatment and control groups were 74.17% ± 30.84% and 51.87% ± 32.81%, respectively (P ⟨ .05), with mean times to heal (within 60 days) of 13.54 ± 9.18 days and 21.5 ± 11.98 days, respectively (P ⟨ .05). There were no serious adverse events in either group, and no complications related to ADM paste application.

CONCLUSIONS:
The ADM paste effectively enhanced tissue regeneration, shortening ulcer duration and preventing associated complications, while eliminating the need for supplemental ulcer management procedures. The paste formulation of ADM provides a matrix for tissue ingrowth, promoting the healing of DFUs.
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NewsBot · Feb 26, 2020

The Efficacy and Safety of Acellular Matrix Therapy for Diabetic Foot Ulcers: A Meta-Analysis of Randomized Clinical Trials.
Huang W et al
J Diabetes Res. 2020 Feb 1

BACKGROUND:
Acellular matrix (AM) therapy has shown promise in the treatment of diabetic foot ulcers (DFUs) in several studies. The clinical effects of AM therapy were not well established. Therefore, we conducted a meta-analysis of randomized clinical trials (RCTs) to examine the efficacy and safety of AM therapy for patients with DFUs.

METHODS:
A literature search of 5 databases was performed to identify RCTs comparing AM therapy to standard therapy (ST) in patients with DFUs. The primary outcome was the complete healing rate and the secondary outcomes mainly included time to complete healing and adverse events.

RESULTS:
Nine RCTs involving 897 patients were included. Compared with ST group, patients allocated to AM group had a higher complete healing rate both at 12 weeks (risk ratio (RR) = 1.73, 95% confidence interval (CI): 1.31 to 2.30) and 16 weeks (RR = 1.56, 95% CI: 1.28 to 1.91), a shorter time to complete healing (mean difference (MD) = -2.41; 95% CI: -3.49 to -1.32), and fewer adverse events (RR = 0.64, 95% CI: 0.44 to 0.93).

CONCLUSION:
The present study suggests that AM therapy as an adjuvant treatment could further promote the healing of full-thickness, noninfected, and nonischemia DFUs. AM therapy also has a safety profile. More large well-designed randomized clinical trials with long follow-up duration are needed to further explore the efficacy and safety of AM therapy for DFUs.
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NewsBot · Feb 22, 2021

The effectiveness of a new dried human amnion derived membrane in addition to standard care in treating diabetic foot ulcers: A patient and assessor blind, randomised controlled pilot study
Fran Game Katie Gray Daniel Davis Rachelle Sherman Kamal Chokkalingam Zak Connan Apostolos Fakis Michael Jones
19 February 2021

Recent reviews suggest that amniotic membrane products may accelerate healing of diabetic foot ulcers. A new dried human amniotic membrane (dHAM) has been used for ocular ulcers but not for diabetic foot ulcers. This was a multi‐centre, prospective, patient and observer blind, randomised controlled pilot trial, to investigate whether 2 weekly addition of the dHAM to standard care versus standard care alone increased the proportion of healed participants' index foot ulcers within 12 weeks. Thirty‐one people (mean age 59.8 years, 81% male, 87% type 2 diabetes) were randomised (15 dHAM, 16 usual care). Within 12 weeks, healing occurred in 4 (27%) ulcers in the dHAM group versus 1 (6.3%) usual care group (P = .1). Percentage wound area reduction was higher in the dHAM versus control group. (P = .0057). There was no difference in AEs between the two groups. Six participants allocated to dHAM correctly identified their treatment group, although 5 in usual care incorrectly thought they were in the intervention arm. This pilot trial result is encouraging showing that this dHAM preparation is safe and promising treatment. These results will be used to design a statistically powered, definitive double blind randomised controlled trial.
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NewsBot · Feb 22, 2021

Systematic review on the rational use of amniotic membrane allografts in diabetic foot ulcer treatment
Kasun Lakmal et al
BMC Surg. 2021 Feb 15;21(1):87

Background: Diabetic foot ulcer is a complication with multiple aetiological factors which has a significant impact to patients' lives and costs to the healthcare system. The potential of human amniotic membrane to act as an allograft has been studied in relation to this condition. Aim of this study is to evaluate the current scientific evidence on its effectiveness in healing diabetic foot ulcers.

Methods: Pubmed, Cochrane library, and Google scholar were searched using the search terms, "Amnion" OR "Placenta" AND "Diabetic foot". (MeSH terms) in the title or the abstract field from 1st of January 2000 to 30th March 2020. The quality of published reports was assessed using standard methods. We searched for experimental and observational studies in terms of randomized control trials, prospective cohort, retrospective cohort studies and case series.

Results: When searched with Mesh terms, 12 citations in PubMed, 22 citations in Cochrane library and 30 in other data bases were found. After screening the studies and their reference lists, 12 studies met the inclusion criteria and the others were excluded. There were 8 randomized control trials (RCTs), 2 prospective studies and 2 retrospective studies employing different preparation methods of the amniotic membranes. A wide variation in study end points were noted. Majority of the RCTs (n = 7) were concluded with significantly higher wound closure rate compared to the conventional treatment groups. In prospective and retrospective studies, it was shown that large chronic ulcers which were resistant to closure with standard therapy achieved wound closure with amniotic membrane allografts. A meta-analysis could not be performed due to study heterogeneity, and publication bias was not assessed due to the small number of available studies which was not sufficient for accurate comparison.

Conclusion: Even though, the studies had some inherent heterogeneity due to different preparation methods, different study end points and outcome measurements. According to our review the current studies using amniotic membrane allografts give reliable evidence of reduction in healing time over conventional methods.
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NewsBot · Apr 18, 2021

Ready-to-Use Micronized Human Acellular Dermal Matrix to Accelerate Wound Healing in Diabetic Foot Ulcers: A Prospective Randomized Pilot Study
Hyung Min Hahn, Dong Hwan Lee, Il Jae Lee
Adv Skin Wound Care. 2021 May 1;34(5):1-6

Objective: To examine and report clinical outcomes of a ready-to-use micronized dermal matrix for diabetic foot ulcers (DFUs) and compare it to treatment with conventional negative-pressure wound therapy (NPWT) only.

Methods: The researchers randomly allocated 30 DFUs Wagner grade 2 or higher from 30 adult patients into two groups. The control group (n = 15) was treated with conventional NPWT, and the experimental group (n = 15) was treated with micronized dermal matrix and NPWT. The researchers evaluated the following outcomes: granulation tissue formation, proportion of patients with closed or granulated wounds at 42 and 120 days, achievement of complete wound healing in the 6 months of follow-up, and intervals from enrollment to final surgical procedures.

Results: All 15 wounds treated with the micronized matrix showed healthy granulation tissue without noticeable complications during follow-up. At 42 days, 46.7% of wounds in the experimental group had closed compared with 28.6% in the conventional NPWT group (P = .007). At 120 days, 86.7% of the experimental group had completely closed wounds, compared with 57.1% in the conventional therapy group (P = .040). During the 6-month follow-up period, 93.3% of the experimental group achieved complete wound healing compared with 85.7% of the conventional therapy group (P = .468).

Conclusions: The healing outcomes for DFUs in the experimental group were superior when micronized matrix treatment was combined with NPWT.
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NewsBot · Jul 4, 2021

Acellular Dermal Matrix Used in Diabetic Foot Ulcers: Clinical Outcomes Supported by Biochemical and Histological Analyses
Ferdinando Campitiello et al
Int J Mol Sci. 2021 Jun 30;22(13):7085.

Diabetic foot ulcer (DFU) is a diabetes complication which greatly impacts the patient's quality of life, often leading to amputation of the affected limb unless there is a timely and adequate management of the patient. DFUs have a high economic impact for the national health system. Data have indeed shown that DFUs are a major cause of hospitalization for patients with diabetes. Based on that, DFUs represent a very important challenge for the national health system. Especially in developed countries diabetic patients are increasing at a very high rate and as expected, also the incidence of DFUs is increasing due to longevity of diabetic patients in the western population. Herein, the surgical approach focused on the targeted use of the acellular dermal matrix has been integrated with biochemical and morphological/histological analyses to obtain evidence-based information on the mechanisms underlying tissue regeneration. In this research report, the clinical results indicated decreased postoperative wound infection levels and a short healing time, with a sound regeneration of tissues. Here we demonstrate that the key biomarkers of wound healing process are activated at gene expression level and also synthesis of collagen I, collagen III and elastin is prompted and modulated within the 28-day period of observation. These analyses were run on five patients treated with Integra® sheet and five treated with the injectable matrix Integra® Flowable, for cavitary lesions. In fact, clinical evaluation of improved healing was, for the first time, supported by biochemical and histological analyses. For these reasons, the present work opens a new scenario in DFUs treatment and follow-up, laying the foundation for a tailored protocol towards complete healing in severe pathological conditions.
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NewsBot · Jul 17, 2022

Acellular dermal matrix decorated with collagen-affinity peptide accelerate diabetic wound healing through sustained releasing Histatin-1 mediated promotion of angiogenesis
Yanpeng Cao et al
Int J Pharm. 2022 Jul 12

Treating diabetic ulcers is a major challenge in clinical practice, persecuting millions of patients with diabetes and increasing the medical burden. Recombinant growth factor application can accelerate diabetic wound healing via angiogenesis. The local administration of recombinant growth factors has no robust clinical efficiency because of the degradation of append short duration of the molecules in the hostile inflammatoryenvironment.The present study focused on the pathophysiology of impaired neovascularization and growth factor short duration in the diabetic wound. We prepared a collagen-binding domain (CBD)-fused recombinant peptide (C-Histatin-1) that had both pro-angiogenesis capacity and collagen-affinity properties. Next, we created a biocompatible acellular dermal matrix (ADM) as a drug delivery carrier that featured collagen-richness, high porosity, and non-cytotoxicity. C-Histatin-1 was then tethered on ADM to obtain a sustained-release effect. Finally, a functional scaffold (C-Hst1/ADM) was developed. C-Hst1/ADM can sustain-release Histatin-1 to promote the adhesion, migration, and angiogenesisof vascular endothelial cells in vitro. Using a diabetic wound model, we showed that C-Hst1/ADM could significantly promote angiogenesis, reduce scar widths, and improve extracellular collagen accumulation. Therefore, the results of this study provide a foundation for the clinical application of C-Hst1/ADM covering scaffold in the treatment of diabetic wounds.
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NewsBot · Dec 28, 2023

Early identification of delayed wound healing in complex diabetic foot ulcers treated with a dermal regeneration template: A novel clinical target and its risk factors
Ting-Yu Tai et al
Int J Surg. 2023 Dec 12

Background: The dermal regeneration template (DRT), a tissue-engineered skin substitute composing a permanent dermal matrix and an upper temporary silicone layer that serves as the epidermis, has demonstrated efficacy in treating uncomplicated diabetic foot ulcers (DFUs). Our institution has obtained good outcomes with DRT in patients with more complicated DFUs. Because of its chronicity, we are working to identify a clinical target that anticipates delayed healing early in the treatment in addition to determining the risk factors linked to this endpoint to increase prevention.

Materials and methods: This retrospective single-center study analyzed patients with DFUs who underwent wound reconstruction using DRT between 2016 and 2021. The patients were categorized into poor or good graft-take groups based on their DRT status on the 21st day after the application. Their relationship with complete healing rate at day 180 was analyzed. Variables were collected for risk factors for poor graft take at day 21. Independent risk factors were identified after multivariable analysis. The causes of poor graft take were also reported.

Results: This study examined 80 patients (38 and 42 patients in the poor and good graft-take groups, respectively). On day 180, the complete healing rate was 86.3% overall, but the poor graft-take group had a significantly lower complete healing rate (76.3% vs. 95.2%, P = 0.021) than the good graft-take group. Our analysis identified four independent risk factors: transcutaneous oxygen pressure < 30 mmHg (odds ratio, 154.14), off-loading device usage (0.03), diabetic neuropathy (6.51), and toe wound (0.20). The most frequent cause of poor graft take was infection (44.7%), followed by vascular compromise (21.1%) and hematoma (15.8%).

Conclusion: Our study introduces the novel concept of poor graft take at day 21 associated with delayed wound healing. Four independent risk factors were identified, which allows physicians to arrange interventions to mitigate their effects or select patients more precisely. DRT represents a viable alternative to address DFUs, even in complicated wounds. A subsequent split-thickness skin graft is not always necessary to achieve complete healing.
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NewsBot · Jan 4, 2024

Acellular Dermal Matrix for Treatment of Diabetic Foot Ulcer: An Overview of Systematic Reviews
Li Lingyan et al
Int J Low Extrem Wounds. 2023 Nov 28

Aims: To evaluate the reliability of the methodological quality and outcome measures of systematic reviews (SRs)/metaanalyses (MAs) of the acellular dermal matrix (ADM) for diabetic foot ulcer (DFU). Methods: We searched and retrieved SRs and MAs on the application of ADM for DFU from PubMed, Web of Science, The Cochrane Library, EMBASE, CNKI, CBM, WanFang, and VIP databases. We employed AMSTAR 2 to assess methodological quality, Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system to grade, and the strength of evidence of included SRs/MAs. We excluded the overlapping randomized controlled trials (RCTs) and conducted a re-MA of the primary RCTs. Results: A total of 7 SRs/MAs were included. Results from the AMSTAR 2 evaluation revealed a low overall quality; the GRADE system showed that the evidence was of moderate to very low quality. Our re-MA showed that ADM was superior to standard of care (SOC), with regards to complete wound healing rate at 12 weeks (RR = 1.74, 95% CI:1.34-2.25, P < .0001), complete wound healing rate at 16 weeks (RR = 1.50, 95% CI: 1.26-1.77, P ＜ .00001); healing time (MD = -2.06, 95% CI: -2.57 to -1.54, P < .00001) and adverse events (RR = 0.62, 95% CI: 0.49-0.80, P = .0002). However, a consensus has not yet been reached between ADM and SOC groups with regard to outcome indicators of the reduction of ulcer area and quality of life; and subgroup analyses showed no statistically significant differences between the xenograft ADM and SOC groups (RR = 1.36, 95% CI: 0.95-1.93, P = .09) at 12 weeks. Conclusion: Current evidence suggests that ADM is more effective than the standard of care in the treatment of DFU, particularly for full-thickness, noninfected, and nonischemic foot ulcers, but with low evidence quality. Therefore, the results of this overview should be interpreted dialectically and prudently, and the role of ADM in DFU needs further exploration
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NewsBot · Mar 6, 2024

Effectiveness and safety of dermal matrix used for diabetic foot ulcer: a systematic review and meta-analysis of randomized controlled trials
Lei Sui et al
BMC Endocr Disord. 2024 Feb 20;24(1):23

Background: Diabetic foot ulcers (DFUs) have become a global health concern, which can lead to diabetic foot infection (DFI), lower leg amputation, and even mortality. Though the standard of care (SOC) practices have been recognized as the "gold standard" for DFU care, SOC alone may not be adequate to heal all DFUs and prevent their recurrence. The use of dermal matrix has emerged as an adjuvant treatment to enhance DFU healing. The current study aimed to evaluate the effectiveness and safety of dermal matrix application as an adjuvant treatment to the SOC.

Methods: The databases of PubMed, Embase and CENTRAL were independently searched by two authors, with the following key terms: "diabetic foot ulcer", "acellular dermal matrix", "wound healing", and so on. Randomized controlled trials (RCTs) evaluated the efficacy and safety of dermal matrix in the treatment of DFUs were eligible for inclusion. The primary outcomes analyzed included time to complete healing and complete healing rate at the final follow-up, while secondary outcomes included wound area, ulcer recurrence rate, amputation risk and complication risk. Meta-analyses were performed using random-effect or fixed-effect models, based on the heterogeneity test.

Results: This study included a total of 15 RCTs with a total of 1524 subjects. Of these, 689 patients were treated with SOC alone, while 835 patients received SOC plus dermal matrix. Compared to the SOC group, significantly shorter time (MD = 2.84, 95%CI: 1.37 ~ 4.32, p < 0.001***) was required to achieve complete healing in dermal matrix group. Significantly higher complete healing rate (OR = 0.40, 95%CI: 0.33 ~ 0.49, p < 0.001***) and lower overall (RR = 1.83, 95%CI: 1.15 ~ 2.93, p = 0.011*) and major (RR = 2.64, 95%CI: 1.30 ~ 5.36, p = 0.007**) amputation risks were achieved in dermal matrix group compared to SOC group. No significant difference was found in the wound area, ulcer recurrence rate, and complication risk between the two groups.

Conclusions: The application of dermal matrix as an adjuvant therapy in conjunction with SOC effectively improved the healing process of DFUs and reduced the amputation risk when compared to SOC alone. Furthermore, dermal matrix application was well tolerated by the subjects with no added complication risk.
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