Sucrose octasulfate dressings for the neuroischaemic diabetic foot ulcer

NewsBot · Dec 21, 2017

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Sucrose octasulfate dressing versus control dressing in patients with neuroischaemic diabetic foot ulcers (Explorer): an international, multicentre, double-blind, randomised, controlled trial
Prof Michael Edmonds et al
The Lancet Diabetes & Endocrinology

Background
Diabetic foot ulcers are serious and challenging wounds associated with high risk of infection and lower-limb amputation. Ulcers are deemed neuroischaemic if peripheral neuropathy and peripheral artery disease are both present. No satisfactory treatment for neuroischaemic ulcers currently exists, and no evidence supports one particular dressing. We aimed to assess the effect of a sucrose octasulfate dressing versus a control dressing on wound closure in patients with neuroischaemic diabetic foot ulcers.

Methods
We did a randomised, double-blind clinical trial (Explorer) in 43 hospitals with specialised diabetic foot clinics in France, Spain, Italy, Germany, and the UK. Eligible participants were inpatients or outpatients aged 18 years or older with diabetes and a non-infected neuroischaemic diabetic foot ulcer greater than 1 cm2 and of grade IC or IIC (as defined by the University of Texas Diabetic Wound Classification system). We excluded patients with a severe illness that might lead to them discontinuing the trial and those who had surgical revascularisation in the month before study entry. We randomly assigned participants (1:1) via a computer-generated randomisation procedure (concealed block size two); stratified by study centre and wound area (1–5 cm2 and 5–30 cm2), to treatment with either a sucrose octasulfate wound dressing or a control dressing (the same dressing without sucrose octasulfate) for 20 weeks. Both groups otherwise received the same standard of care for a 2-week screening period before randomisation and throughout the 20-week trial. Dressings were applied by nursing staff (or by instructed relatives for some outpatients). Frequencies of dressing changes were decided by the investigator on the basis of the clinical condition of the wound. Patients were assessed 2 weeks after randomisation, then monthly until week 20 or occurrence of wound closure. The primary outcome, assessed by intention-to-treat, was proportion of patients with wound closure at week 20. This trial is registered with ClinicalTrials.gov, number NCT01717183.

Findings
Between March 21, 2013, and March 31, 2016, we randomly assigned 240 individuals to treatment: 126 to the sucrose octasulfate dressing and 114 to the control dressing. After 20 weeks, wound closure occurred in 60 patients (48%) in the sucrose octasulfate dressing group and 34 patients (30%) in the control dressing group (18 percentage points difference, 95% CI 5–30; adjusted odds ratio 2·60, 95% CI 1·43–4·73; p=0·002). In both groups, the most frequent adverse events were infections of the target wound: 33 wound infections in 25 (20%) patients of 126 in the sucrose octasulfate dressing group and 36 in 32 (28%) patients of 114 in the control dressing group. Minor amputations not affecting the wound site were also reported in one (1%) patient in the sucrose octasulfate dressing group and two (2%) patients in the control dressing group. Three (2%) patients assigned to the sucrose octasulfate dressing and four (4%) assigned to the control dressing died, but none of the deaths were related to treatment, procedure, wound progression, or subsequent to amputation.

Interpretation
A sucrose octasulfate dressing significantly improved wound closure of neuroischaemic diabetic foot ulcers without affecting safety after 20 weeks of treatment along with standard care. These findings support the use of sucrose octasulfate dressing as a local treatment for neuroischaemic diabetic foot ulcers.
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NewsBot · Aug 31, 2020

Increasing Transcutaneous Oxygen Pressure in Patients With Neuroischemic Diabetic Foot Ulcers Treated With a Sucrose Octasulfate Dressing: A Pilot Study
José Luis Lázaro-Martínez et al
Int J Low Extrem Wounds. 2020 Aug 28

Regarding the positive clinical outcomes of sucrose octasulfate impregnated dressing documented in neuroischemic diabetic foot ulcers (DFUs), we aimed to evaluate the microcirculatory status in patients with neuroischemic DFU through the use of sucrose octasulfate dressing. Eleven patients with neuroischemic DFU were included in a prospective pilot study between July 2019 and March 2020. We evaluated the effect in transcutaneous oxygen pressure (TcPO2; mm Hg) values within the use of a sucrose octasulfate dressing in the course of the healing process of neuroischemic DFUs (UrgoStart Contact, Laboratoires Urgo Medical). TcPO2 values were assessed at day 0 and monthly until wound healing was achieved. Additionally, wound healing process was evaluated using the Wollina score system and wound area surface, at day 0 and monthly until 20 weeks of follow-up or wound healing first occurred. TcPO2 values showed a significant increase between day 0 (29.45 ± 7.38 mm Hg) and wound closure (46.54 ± 11.45 mm Hg, P = .016), after dressing application. Wollina wound scores showed a significant improvement (4.2 ± 1.7 at day 0 to 5.4 ± 1.3 at the end of the study; P = .004). Median wound area at day 0 was 1.30 cm2, interquartile range [1.60-1] cm2, and 0.5 cm2 at week 4, interquartile range [1.1-0.1], P < .001. Median healing time was 8 weeks, interquartile range [8-5]. Treating a neuroischemic DFU with a sucrose octasulfate dressing in the standard of care showed an increase in skin oxygen pressure.
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NewsBot · Oct 20, 2020

Impact of wound duration on diabetic foot ulcer healing: evaluation of a new sucrose octasulfate wound dressing
Ralf Lobmann, Arthur Grünerbel, Holger Lawall, Claas Lüdemann, Stephan Morbach, Wolfgang Tigges, Lukas Völkel, Reinhard PT Rychlik
Journal of Wound CareVol. 29, No. 10 Practice:14 Oct 2020

Objective:
A common and frequent complication of diabetes is diabetic foot ulcers (DFU), which can have high treatment costs and severe adverse events. This study aims to evaluate the effects of wound duration on wound healing and the impact on costs, including treatment with a new sucrose octasulfate dressing compared with a control dressing.

Method:
Based on the Explorer study (a two-armed randomised double-blind clinical trial), a cost-effectiveness analysis compared four different patient groups distinguished by their wound duration and additionally two DFU treatment options: a sucrose octasulfate dressing and a neutral dressing (as control). Clinical outcomes and total direct costs of wound dressings were evaluated over 20 weeks from the perspective of the Social Health Insurance in Germany. Simulation of long-term outcomes and costs were demonstrated by a five cycle Markov model.

Results:
The results show total wound healing rates between 71% and 14.8%, and direct treatment costs for DFU in the range of €2482–3278 (sucrose octasulfate dressing) and €2768–3194 (control dressing). Patients with a wound duration of ≤2 months revealed the highest wound healing rates for both the sucrose octasulfate dressing and control dressing (71% and 41%, respectively) and had the lowest direct treatment costs of €2482 and €2768, respectively. The 100-week Markov model amplified the results. Patients with ≤2 months' wound duration achieved wound healing rates of 98% and 88%, respectively and costs of €3450 and €6054, respectively (CE=€3520, €6864). Sensitivity analysis revealed that the dressing changes per week were the most significant uncertainty factor.

Conclusion:
Based on the findings of this study, early treatment of DFU with a sucrose octasulfate dressing is recommended from a health economic view due to lower treatment costs, greater cost-effectiveness and higher wound healing rates.
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NewsBot · Feb 2, 2023

Microcirculation Improvement in Diabetic Foot Patients after Treatment with Sucrose Octasulfate-Impregnated Dressings
José Luis Lázaro-Martínez et al
J. Clin. Med. 2023, 12(3), 1040; https://doi.org/10.3390/jcm12031040

To assess the patients’ microcirculation evolution during the treatment with a sucrose octasulfate-impregnated dressing, fifty patients with neuroischaemic DFU treated with TLC-NOSF dressing were included in a prospective study between November 2020 and February 2022. TcpO2 values were measured on the dorsalis pedis or tibial posterior arteries’ angiosome according to the ulcer location. TcpO2 values were assessed at day 0 and every 4 weeks during 20 weeks of the follow-up or until the wound healed. A cut-off point of tcpO2 < 30 mmHg was defined for patients with impaired microcirculation. The TcpO2 values showed an increase between day 0 and the end of the study, 33.04 ± 12.27 mmHg and 40.89 ± 13.06 mmHg, respectively, p < 0.001. Patients with impaired microcirculation showed an increase in the tcpO2 values from day 0 to the end of the study (p = 0.023). Furthermore, we observed a significant increase in the TcpO2 values in the forefoot DFU (p = 0.002) and in the rearfoot DFU (p = 0.071), with no difference between the ulcer locations (p = 0.694). The local treatment with TLC-NOSF dressing improved the microcirculation in patients with neuroischaemic DFU, regardless of microcirculation status at the baseline, and in the forefoot, regardless of the location.
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Sucrose octasulfate dressings for the neuroischaemic diabetic foot ulcer

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Sucrose octasulfate dressings for the neuroischaemic diabetic foot ulcer

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