LeucoPatch for Diabetic Foot Ulcers

NewsBot · Oct 20, 2011

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This clinical trial has just been registered:
LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers

The LeucoPatch™ study goal is to investigate whether the fully autologous growth factor-containing dressing LeucoPatch™ has a positive effect on healing rates of diabetic foot ulcers. The study seeks to gather data for comparison with previous data from similar wounds (historical controls). By subgrouping of the treated wounds (similar to the historical controls used) an assessment of which of the patient and wound-related factors that might indicate a beneficial effect of LeucoPatch™ is sought.
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The goal of the LeucoPatch ™ study is to investigate the effect of LeucoPatch ™ in diabetic foot ulcer. LeucoPatch ™ is a biologically active dressings which are made solely by the patient's own blood (autologous). It is produced in the CE mark LeucoPatch™ Device and contains no additives. In this treatment study up to 50 typical diabetic patients with foot ulcers are included. These wounds are typically chronic and lead to reduced quality of life and ability to work, and extensive treatment costs. Furthermore, these wounds often lead to amputations.The study is a multicenter study in which up to 10 wound clinics are expected to be involved.
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NewsBot · Oct 31, 2011

Re: LeucoPatch™ for Diabetic Foot Ulcers

A Pilot Study of Leucopatch, an Autologous, Additive-Free, Platelet-Rich Fibrin for the Treatment of Recalcitrant Chronic Wounds to Determine Safety
Bo Jørgensen et al
International Journal of Lower Extremity Wounds October 18, 2011

This prospective, uncontrolled pilot study evaluated the safety and clinical performance of Leucopatch an additive-free, autologous platelet-rich fibrin in the treatment of recalcitrant chronic wounds. Fifteen patients, with 16 lower extremity chronic wounds of varying etiologies were treated weekly with Leucopatch, prepared at the point of care from a donation of the patients’ blood, for 6 weeks, or until healing was complete. The wounds had been present for 2 to 108 months (median 24 months) and ranged in size from 0.4 to 15.7 cm2 (median 2.3 cm2) and had not responded to previous treatments. Of the 13 wounds (12 patients) included in the per-protocol efficacy analysis, 4 healed completely (31%). Mean wound area decreased significantly by 65% (95% confidence interval = 45.6% to 83.8%) resulting in a median wound size of 0.9 cm2 (range = 0-9.6cm2). There were no serious adverse events. Two adverse events, one of noncompliance and one infection, were observed; neither was considered to be related to treatment. The results indicate that Leucopatch is easy to prepare and apply in the clinic, is safe, and may be a clinically effective treatment of recalcitrant chronic wounds.
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NewsBot · Jun 17, 2014

Re: LeucoPatch™ for Diabetic Foot Ulcers

Treatment of Hard-to-Heal Diabetic Foot Ulcers Probing to Bone with Leucopatch™, a Leukocytes and Platelet Rich Fibrin Patch
PER KATZMAN, KATARINA FAGHER, RASMUS LUNDQUIST, MAGNUS LÖNDAHL
Presented at the 74th American Diabetes Association Mtg; San Francisco; June 14-17 2014

Autologous platelet-rich fibrin, a treatment containing fibrin and high concentrations of growth factors, has been used for treatment of diabetic foot ulcers. Recently, a novel treatment, Leucopatch™ using viable leucocytes in an autologous platelet-rich fibrin patch has been introduced. LeucoPatch™ is produced from patient's own venous blood, without anticoagulant or any other additives. To produce one patch (5cm2 area), 18 mL of the patient´s own blood is drawn into a Leucopatch™ device, and spinned for 20 minutes. Initial studies indicate that this treatment might enhance healing of Wagner grade 1-2 foot ulcers in diabetic patients.

The aim of the present cases series was to elucidate the feasibility of Leucopatch™ treatment in at least Wagner grade 3 diabetic foot ulcers i.e. ulcers with positive probing to bone test. Patients with non-ischemic (TcPO2≥ 30 mm Hg) diabetic foot ulcers with a duration of at least 6 weeks and a positive probing to bone test were consecutively offered this treatment. The ulcer was covered by a gentamycin dressing the week before the first Leucopatch™ treatment. Leucopatch™ was then applied once weekly for up to 20 weeks. All patients were on oral antibiotic treatment at least until bone coverage was achieved, and thereafter at the discretion of the physician.

In this small case series 17 patients and 21 ulcers were treated with Leucopatch™. Median ulcer duration was 27 weeks and the median number of treatments was 9. Bone was covered in 16 ulcers of which 13 healed with complete epithelialization. A tissue infection occurred in three cases, but resolved after change of oral antibiotic treatment. Bone resection was performed in two cases and distal phalangeal resection in one case.

Leucopatch™ seems to be safe to apply to bone surface in diabetic foot ulcers. The efficacy needs to be proven before routine clinical use can be recommended.
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NewsBot · Aug 25, 2014

Re: LeucoPatch™ for Diabetic Foot Ulcers

Another clinical trial on this just registered:
LeucoPatch in the Management of Hard-to-heal Diabetic Foot Ulcers

Diabetic foot ulcers are the source of considerable suffering and cost and there are currently no wound care products available that have been demonstrated to improve healing, or that are cost effective. There have however been a small number of studies which have examined the use of platelets or fluid derived from platelets, either from the patient's own blood or from blood bank products. These have suggested some promise, but have suffered from technical difficulties in making a suitable wound care product or the volume of blood required to derive the product. It is thought that the reason why they may work is that growth factors released by the platelets may stimulate the wound to heal.

This study will be a formal, randomised controlled trial to assess a new device for creating a wound care product which is a plug or patch comprising fibrin, white cells and platelets derived from 18 mls of the patients own blood. The application of this fibrin/white cell/platelet patch to the patients wound on a weekly basis will be compared with usual best care in patients with hard to heal Diabetic Foot Ulcers in a secondary care setting in 25 centres in the United Kingdom, Denmark and Sweden.
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NewsBot · Apr 13, 2016

Press Release:
Reapplix: LeucoPatch Trial to Continue Following Interim Analysis
April 13, 2016

BIRKEROD, Denmark--(BUSINESS WIRE)--Reapplix today announced that it has been informed by the Trial Steering Committee for the ongoing LeucoPatch? Randomized Controlled Trial (ClinicalTrials.gov NCT02224742) that a planned interim analysis has been performed. The purpose of the planned interim analysis was to re-estimate the sample size (up to 352 patients if needed) or to stop for futility. Following the planned interim analysis, Reapplix has been informed that the trial will continue to the originally estimated sample size of 250 participants.

This large scale Randomized Controlled Trial is being conducted in up to 35 centres in UK, Sweden and Denmark. The aim of the Trial is to demonstrate whether the application of LeucoPatch? when used in addition to usual care in a multidisciplinary diabetes foot clinic setting, is superior to usual care alone with regard to complete healing of hard-to-heal diabetic foot ulcers. The study will also provide information on reduction in pain, decrease in ulcer area, amputations, well-being, costs and other clinical outcomes.

Reapplix are providing funding for this trial, which is being run independently by the Sponsors, Nottingham University Hospitals NHS Trust.

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- Notes to editors -

Reapplix have developed a unique device technology for wound care. In Europe, this technology is known as the LeucoPatch? System and is undergoing both clinical evaluation and commercial market testing. In the LeucoPatch? System, blood is collected from the patient in a single use LeucoPatch? Device, which is effectively a precision engineered mini cell processor. The LeucoPatch? Device, in combination with the LeucoPatch 3CP™ Centrifuge, uses the patent protected 3CP™ Technology to produce each autologous LeucoPatch? on demand using a simple to use process, with no reagents, which fits in well with existing clinical work flow.

LeucoPatch? is currently being used at selected centres across Europe to treat a variety of hard to heal wounds. In addition to this, LeucoPatch? is being evaluated for the treatment of diabetic foot ulcers in a randomized controlled clinical study that is expected to be completed in 2017. Diabetic foot ulcers are associated with high morbidity and substantial health care costs as up to 40% of diabetic foot ulcer wounds remain unhealed after one year using current standards of care. Given these market dynamics, there is a clear need for a cost-effective and efficacious treatment option.

In February 2016, Reapplix’s unique technology - a single use medical device used to prepare an autologous platelet-rich plasma (PRP) gel from the patient’s peripheral blood by centrifugation, without the addition of any reagents - received US FDA 510(k) clearance to be put on market in the US as the 3C Patch System™, with the indication for use that under the supervision of a healthcare professional, the PRP gel produced by the 3C Patch System™ is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and mechanically or surgically-debrided wounds.

Reapplix ApS is a privately-held wound care company backed by three leading Danish investors, Seed Capital, Novo SEEDS and V?kstfonden (The Danish Growth Fund).

www.reapplix.com
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NewsBot · Sep 24, 2018

LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked, randomised controlled trial.
Game F et al
Lancet Diabetes Endocrinol. 2018 Sep 19.

BACKGROUND:
The LeucoPatch device uses bedside centrifugation without additional reagents to generate a disc comprising autologous leucocytes, platelets, and fibrin, which is applied to the surface of the wound. We aimed to test the effectiveness of LeucoPatch on the healing of hard-to-heal foot ulcers in people with diabetes.

METHODS:
This was a multicentre, international, observer-masked, randomised controlled trial of people with diabetes and a hard-to-heal foot ulcer done in 32 specialist diabetic foot clinics in three countries (UK, Denmark, and Sweden). After a 4-week run-in period, those with a reduction in ulcer area of less than 50% were randomly allocated (1:1) by computer-generated, web-based randomisation (block sizes of two, four, and six) to either prespecified good standard care alone or care plus weekly application of LeucoPatch. The primary outcome was the proportion of ulcers that healed within 20 weeks assessed in the intention-to-treat population (all participants with post-randomisation data collected), defined as complete epithelialisation (confirmed by an observer who was masked to randomisation group), and remained healed for 4 weeks. This trial is registered with the ISRCTN registry, number 27665670, and ClinicalTrials.gov, number NCT02224742.

FINDINGS:
Between Aug 30, 2013, and May 3, 2017, 269 participants were randomly allocated to receive treatment (137 to receive standard care and 132 to receive LeucoPatch). The mean age was 61·9 years (SD 11·6), 217 (82%) were men, and 222 (83%) had type 2 diabetes. In the LeucoPatch group, 45 (34%) of 132 ulcers healed within 20 weeks versus 29 (22%) of 134 ulcers in the standard care group (odds ratio 1·58, 96% CI 1·04-2·40; p=0·0235) by intention-to-treat analysis. Time to healing was shorter in the LeucoPatch group (p=0·0246) than in the standard care group. No difference in adverse events was seen between the groups. The most common serious adverse event (SAE) was diabetic foot infection (24 events in the LeucoPatch group [24% of all SAEs] and 20 in the standard care group [27% of all SAEs]. There were no device-related adverse events.

INTERPRETATION:
The use of LeucoPatch is associated with significant enhancement of healing of hard-to-heal foot ulcers in people with diabetes.
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NewsBot · Oct 26, 2023

Retrospective Data Analysis of the Use of an Autologous Multilayered Leukocyte, Platelet, and Fibrin Patch for Diabetic Foot Ulcers Treatment in Daily Clinical Practice
Jason M Mendivil et al
Adv Skin Wound Care. 2023 Nov 1;36(11):579-585

Objective: To describe the healing outcome of chronic, hard-to-heal diabetic foot ulcers (DFUs) treated with an autologous multilayered leukocyte, platelet, and fibrin (MLPF) patch in addition to the best standard of care, in a real-world clinical setting of two US amputation preventive centers.

Methods: In this retrospective study of patients treated between September 2021 and October 2022, the authors analyzed DFU healing outcomes based on Wound, Ischemia, and foot Infection-derived amputation risk.

Results: All 36 patients had a diagnosis of type 2 diabetes and 29 (81%) were male. Their average age was 61.4 years, body mass index was 29.2 kg/m2, and glycated hemoglobin was 7.9. Twenty-seven patients (78%) were diagnosed with peripheral vascular disease, 20 (56%) underwent a peripheral vascular procedure, 15 (42%) had a prior amputation, and 6 (17%) were on hemodialysis. Average wound size was 4.9 cm2, and wound age was 9.5 months. Twelve patients (32%) were classified as low risk, 15 (39%) as moderate risk, and 11 (29%) as high risk for amputation. Within 12 weeks of the first MLPF patch application, nine wounds (24%) healed. After 20 weeks, 23 wounds (61%) were closed, and by follow-up, 30 wounds (79%) healed. No amputations were noted. Compared with published data, 40% fewer patients underwent readmission within 30 days, with 72% shorter admission duration.

Conclusions: Real-world clinical experiences using the MLPF patch to treat hard-to-heal DFUs resulted in the majority of wounds healing. Few patients experienced a readmission within 30 days, and the average admission duration was short.
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