An interventional study of Tri-Membrane Wrap™ DFU and Membrane Wrap™ DFU in Diabetic Foot Ulcer, Foot Ulcer Chronic and DFU, sponsored by BioLab Holdings. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by BioLab Holdings · Not applicable, Interventional, and Treatment
The study is a multicenter, prospective, controlled modified multi-platform trial assessing the efficacy of human placental membrane products and standard of care in the management of nonhealing diabetic foot ulcers and venous leg ulcers.
This study follows a rescue design: patients in the SOC arm who fail to heal during the BIOCAMP Prospective Modified Dual Platform Multicenter Randomized Controlled Clinical Trial will enter the Rescue trial and receive one of the study products.
Patients enrolled in this trial must still meet medical necessity criteria for cellular, acellular, matrix-like, products (CAMPs) recently published by the Medicare Administrative Contractor's (MAC) in their local coverage determinations (LCD).
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →BioLab Holdings is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tri-Membrane Wrap™ is an allograft derived from human amniotic membrane.
Other: Tri-Membrane Wrap™ DFU
Membrane Wrap™ is an allograft derived from human amniotic membrane.
Other: Membrane Wrap™ DFU
Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane.
Other: Membrane Wrap-Lite™ DFU
Membrane Wrap-Hydro™ is an allograft derived from human amniotic membrane.
Other: Membrane Wrap-Hydro™ DFU
Tri-Membrane Wrap™ is an allograft derived from human amniotic membrane.
Other: Tri-Membrane Wrap™ VLU
Membrane Wrap™ is an allograft derived from human amniotic membrane.
Other: Membrane Wrap™ VLU
Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane.
Other: Membrane Wrap-Lite™ VLU
Membrane Wrap-Hydro™ is an allograft derived from human amniotic membrane.
Other: Membrane Wrap-Hydro™ VLU
Participants will receive weekly applications of Tri-Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Membrane Wrap-Lite™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Membrane Wrap-Hydro™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Tri-Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Membrane Wrap-Lite™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Membrane Wrap-Hydro™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Percentage of Wound Closure
The percentage of target ulcers achieving complete wound closure in 12 weeks.
Time frame: 1-12 Weeks
Time to Closure
Time to closure for the target ulcer.
Time frame: 1-12 weeks
Percentage Area Reduction
Percentage wound area reduction from TV-1 to TV-13 measured weekly with digital photographic planimetry, using imaging device, and physical examination.
Time frame: 1-12 weeks
Adverse Events
The number of product- or procedure- related adverse events.
Time frame: 1-12 Weeks
Determine improvement in Quality of Life
To determine the between-arm difference in the quality of life for subjects receiving HPM plus SOC compared to SOC alone using the Forgotten Wound Score (FWS) questionnaire. Forgotten wound scores situations on a scale of "never" to "mostly."
Time frame: 1-12 weeks
Determine improvement in Quality of Life
To determine the between-arm difference in the quality of life for subjects receiving HPM plus SOC compared to SOC alone using the Wound Quality of Life (wQOL) questionnaire. Scores on a scare from "Not at all" to "Very much."
Time frame: 1-12 weeks
Pain in patients who present with VAS greater than 4
To determine the between-arm difference in pain for patients that present with a Visual Analog Sale (VAS) score of greater than 4. The VAS has a scale of 0-10. 0 Meaning no pain and 10 being the worst pain
Time frame: 1-12 Weeks
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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