A Multicenter Hybrid Platform Trial Comparing the Effects of a Prospective Cohort Treated With a Tri-Layer Amnion Graft or a Single Layer Amnion Graft to a Coarsened Exact Matched Retrospective Control Cohort of Patients With Hard-To-Heal Dfus and Vlus

Studying Special Bandages for Hard-to-Heal Wounds

M
Mithun Sinha

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
75 participants needed
1 Location

Brief description of study

This is a multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a tri layer amnion graft or a single layer amnion graft to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

Hybrid prospective platform 2 arm, comparative, randomized multicenter study with a CSM matched retrospective control group Interventional comparative study

  • IP 1: BioLab Membrane Wrap Lite
  • IP2: BioLab Tri-Membrane Wrap

Standard of care: Debridement, maintenance of proper moisture balance, reduction in bacterial burden, offloading and multilayer compression.

Patients with nonhealing venous leg ulcerations or diabetic foot ulcers of at least 4-weeks duration that have failed to show 50% PAR with SOC therapies Patients receiving SOC therapies for hard-to-heal VLUs and/or DFUs

To gather prospective real-world evidence (RWE) in both diabetic foot ulcers and venous leg ulcers increasing the understanding of treatment performance in everyday clinical settings, capturing insights from a more diverse patient population than traditional clinical trials. This information is vital for evaluating the effectiveness of innovative wound care strategies in practical, real-life scenarios

To demonstrate the clinical effectiveness of IP1 and IP2 as an adjunct to standard of care in supporting wound healing compared to standard of care alone in venous leg ulcers and diabetic foot ulcers across the continuum of care.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Diabetic Foot Ulcer, Venous Leg Ulcer, Foot Wound
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria:

  1. Male or female 18 years of age and older
  2. 2. Subjects having a non-healing venous leg ulcer or diabetic foot ulcer of >4 weeks duration and visible signs of healing objectively, less than 50% reduction in wound size in the last 4 weeks
  3. Subjects' wound size is minimum of 2 cm2 and maximum of 25cm2
  4. If the subject has more than one eligible wound the largest wound will be selected (the index wound)
  5. Subject is able and willing to follow the protocol requirements
  6. Subject has signed informed consent

Exclusion Criteria:

  1. Inability to adhere to the study protocol or study visit schedule
  2. Pregnancy
  3. Child-bearing potential without appropriate contraception
  4. Lactation
  5. Treatment of the wound with engineered tissue or other scaffold materials within 30 days preceding the first treatment visit.
  6. Visible signs of improvement in the four weeks before randomisation (defined objectively as a 50% reduction in surface area in the four weeks before enrolment)
  7. The subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety
  8. Known contraindications to the use of amniotic tissue grafts
  9. The index ulcer shows clinical signs and symptoms of wound infection needing treatment with local or systemic antimicrobials or antibiotics

This study investigates the effects of using a tri-layer amnion graft or a single-layer amnion graft for patients with hard-to-heal diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). These ulcers are wounds that are difficult to heal and may require special treatments. The study compares these treatments to a group of patients who have previously received standard care without these grafts.

Participants in the study will receive either a tri-layer or single-layer amnion graft along with standard care, which includes cleaning the wound, keeping it moist, and reducing bacteria. The study aims to see if the grafts help wounds heal better than standard care alone. A placebo, which is an inactive substance, is not used in this study.

  • Who can participate: Adults aged 18 and older with a non-healing venous leg ulcer or diabetic foot ulcer of more than 4 weeks duration can participate. The wound must be between 2 cm² and 25 cm² in size and not have reduced by 50% in the last 4 weeks. Participants must be able to follow the study protocol and provide informed consent.
  • Study details: Participants will receive either a tri-layer or single-layer amnion graft in addition to standard wound care.
Updated on 27 Oct 2025. Study ID: SURG-CAPSICURE-CAMP-RWE, 28676
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only