Clinical Evidence

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One of few evidence-based wound management procedures

The 3C Patch® is clinically proven to significantly increase the chance of healing of chronic wounds associated with diabetes.

A promise backed with evidence. Proven results including a large RCT published in The Lancet Diabetes & Endocrinology1 and supported with additional solid scientific and clinical data.

Randomized controlled (n= 269) trial published in the Lancet Diabetes & Endocrinology, 2018.

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One of few evidence-based wound treatments, the 3C Patch® is clinically proven to significantly accelerate wound healing of hard-to-heal diabetic foot ulcers.

3C Patch is recommended as adjunctive treatment in hard to heal diabetic foot ulcers.

View IWGDF Guidelines

Pilot Study

Study Design

Prospective, uncontrolled, open-label study evaluating the safety and clinical performance of 3C Patch® in chronic wounds with different etiologies that had failed to heal using conventional, standard treatment approaches. 

*3C Patch is formerly known as Leucopatch

Intervention

3C Patch® was prepared from blood donated by patients at the point of care and applied to their wounds once a week for six weeks, or until the wounds were completely healed. 

Patients

  • 15 patients included
    (16 wounds in total) 

  • Adult patients, with chronic cutaneous ulcers on the lower extremities, chronic diabetic foot ulcers or amputation wounds. DFU grade 1 or 2 according to the Wagner scale 

  • Most of the wounds included in the study had been present for 2 years or more 

By six weeks wound area decreased by a mean of 65%. 

Significantly Increased Granulation

The proportion of granulation tissue present in the wounds increased significantly during the study from a mean of 32% at baseline to 72% at week six.

Significant Decrease in Wound Area

 By six weeks wound area decreased by a mean of 65%. 

Key Safety Data

Only two adverse events recorded, none of which was serious. Neither was considered to be related to the 3C Patch® treatment. No safety issues were identified.

Multicenter Cohort Study

Study Design

Prospective multicenter cohort study of patients with hard-to-heal Wagner grade 1-2 diabetic foot ulcers. 

Intervention

3C Patch® was applied once a week for up to 19 treatments, or until the target ulcer was completely epithelised. In the first treatment session, the ulcer was sharp-debrided before one or two patches were transferred to the ulcer, which was then covered by a primary dressing. Secondary bandages were applied as decided on a case by case basis and changed depending on exudate levels. 

Patients

  • 44 Adult patients, with at least one full-thickness diabetic ulcer, classified by the investigator as Wagner grade 1 or 2 were included 

  • Duration of ulcers was longer than 6 weeks, and the ulcers had a maximal area of 10 cm2 

  • Only "hard-to-heal" ulcers were included, i.e. ulcers that did not reduce more than 40% in area over a 2 week run-in period 

  • 5 patients did not complete the study resulting in Intention To Treat (ITT) and Per Protocol (PP) populations of 44 and 39 respectively 

>70% of ulcers with duration between 8-25 weeks healed. 

Wound Area Change

Average wound area change in response to 3C Patch® treatment (n=39). No average wound area change was seen in the 2 week run-in period (week -2 to 0).

Key Safety Data

No adverse events were judged to be related to the patch treatment. 

Wound Area Change High Healing Rate

>70% of ulcers with duration between 8-25 weeks healed. 

Probe-to-Bone Case Series

Study Design

Open-label, case series evaluating the clinical performance of the 3C Patch® treatment on hard-to-heal DFUs probing to bone. 

Intervention

3C Patch® was prepared during the patient’s visit at the clinic. 18ml of the patient’s own venous blood were drawn and processed for 20 minutes, without anticoagulant or other additives. 

The 3C Patch® (5cm2 area) was applied on the wound surface once a week for up to 20 weeks, or until healing was completed. 

Patients

  • 22 patients included (26 ulcers in total)  

  • Non-ischemic (TcPO2≥ 30 mm Hg) DFUs with a duration of at least 6 weeks and a positive probing to bone test were treated 

  • At least Wagner grade 3 hard-to-heal DFUs probing to bone 

Bone was covered in 70% of the DFUs (18 out of the total 26 DFUs). 

Complete Bone Coverage

Bone was covered in 70% of the DFUs (18 out of the total 26 DFUs). 

Key Safety Data

No serious adverse events were recognized. Tissue infection occurred in three cases but resolved after change of oral antibiotic treatment.

Healing with Complete Epithelialisation

The proportion of granulation tissue present in the wounds increased significantly during the study from a mean of 32% at baseline to 72% at week six. 

International multicenter RCT on 269 hard-to-heal 
patients with diabetes and chronic foot ulcers

Study Design

An independent multicenter, multinational, observer blinded, investigator driven Randomized Controlled Trial on patients with hard-to-heal Wagner grade 1-3 DFUs.

*3C Patch is formerly known as Leucopatch

Intervention

3C Patch® was applied once a week for up to 20 treatments, or until the target ulcer was completely epithelised. In the first treatment session, the ulcer was sharp-debrided before one or two patches were transferred to the ulcer, which was then covered by a primary dressing. Secondary bandages were applied as decided on a case by case basis and changed depending on exudate levels. 

Patients

  • 269 were randomized between August 2013 and May 2017 

  • The groups were well matched at baseline and consisted of those in most need of new treatment, those with “hard-to-heal” DFUs 

  • “Hard-to-heal” defined rigorously as having DFUs that did not reduce in area more than 50% over a 4 week run-in period despite best standard of care according to IGWDF guidelines6 including debridement, offloading etc. as appropriate 

By six weeks wound area decreased by a mean of 65%. 

Complete Wound Closure

58% more patients healed from the intervention compared with best standard of care.

Key Safety Data

No differences in adverse events or serious adverse events between groups. No device related serious adverse events.

Improved Chances of Healing

89% more likely to heal using a linear regression model, defined in the protocol, to account for the wound size distribution between the control and treatment arms (OR 1.89, CI 1.07 – 3.40, p=0.0237).

AT REAPPLIX EVERY WOUND IS PERSONAL AND 
EVERY PATIENT COUNTS

An innovative wound management system, backed by strong clinical evidence
that empowers the patient to be part of their wound healing process - literally!

The use of 3C Patch® usually continues while wound closure is taking place. The timing depends on the specific wound aetiology. See Clinical Data section for a more detailed indication of when wound closure occurs.
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