Diabetic FootPhase 4BIOCAMPNCT07089602
Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
A Phase 4 study testing Tri-Membrane Wrap™ DFU, Membrane Wrap™ DFU and Membrane Wrap-Lite™ DFU in people with Diabetic Foot and DFU, run by BioLab Holdings at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of human placental membrane products and standard of care versus standard of care alone in the management of nonhealing diabetic foot ulcers and venous leg ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, DFU, Diabetic Foot Ulcer
- What is being tested?
- Tri-Membrane Wrap™ DFU, Membrane Wrap™ DFU and Membrane Wrap-Lite™ DFU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2025to Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The potential subject must be at least 18 years of age or older.
- The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.
- At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20 cm2 measured post debridement with the eKare inSight® imaging device.
- The potential subject must have a target ulcer that has been present for a minimum of 4 weeks of standard of care, prior to the initial screening visit.
- The potential subject must have a target ulcer located on the foot with at least 50% of the ulcer below the malleolus.
- The potential subject must have a target ulcer that is Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.
Show all 26Show fewer
- The potential subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
- ABI between 0.7 and ≤ 1.3;
- TBI ≥ 0.6;
- TCOM ≥ 40 mmHg;
- PVR: biphasic.
- If the potential subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
- The potential subject must consent to using the prescribed offloading method for the duration of the study.
- The potential subject must agree to attend the weekly study visits required by the protocol.
- The potential subject must be willing and able to participate in the informed consent process.
- The potential subject must be at least 21 years of age or older.
- At enrollment, the potential subjects must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 20 cm2 measured post-debridement.
- The potential subject must have a target ulcer that has been present for a minimum of 4 weeks of standard of care prior to the initial screening visit.
- The potential subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
- ABI between 0.7 and ≤ 1.3;
- TBI ≥ 0.6;
- TCOM ≥ 40 mmHg;
- PVR: biphasic.
- If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
- The potential subject must agree to attend the weekly study visits required by the protocol.
- The potential subject must be willing and able to participate in the informed consent process.
Who cannot join
- The potential subject is known to have a life expectancy of < 6 months.
- The potential subject's target ulcer is not secondary to diabetes.
- The target ulcer is infected or there is cellulitis in the surrounding skin.
- The target ulcer exposes tendon or bone.
- There is evidence of osteomyelitis complicating the target ulcer.
- There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
Show all 37Show fewer
- The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
- The potential subject is taking hydroxyurea.
- The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
- The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
- The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
- The surface area of the potential subject's target ulcer has reduced in size by more than 40% in the 4 weeks prior to Treatment Visit 1 ("historical" run-in period*). OR The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit AND The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV1) to the TV-1 visit.
- eKare inSight® imaging device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable)
- The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
- The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.
- The potential subject has end stage renal disease requiring dialysis.
- The potential subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
- The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
- The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
- The potential subject has a malnutrition indicator score <17 as measured on the Mini Nutritional Assessment.
- The potential subject is known to have a life expectancy of < 6 months.
- The potential subject's target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
- The potential subject's target ulcer exposes tendon or bone.
- There is evidence of osteomyelitis complicating the potential subject's target ulcer.
- The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
- The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
- The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
- The surface area of the potential subject's target ulcer has reduced in size by more than 40% in the 4 weeks prior to Treatment Visit 1 ("historical" run-in period*). OR The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit AND The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV1) to the TV-1 visit.
- *eKare inSight® imaging device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable)
- The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.
- The potential subject has end stage renal disease requiring dialysis.
- The potential subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
- A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
- The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
- The potential subject has a malnutrition indicator score <17 as measured on the Mini Nutritional Assessment.
- The potential subject has a wound with active or latent infection.
- The subject has a disorder that would create unacceptable risk of post-operative complication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center for Foot and Ankle Disorders
Philidelphia, Pennsylvania, 19146
Ryan Breisinger, 412-965-5737, rbreisinger@serenagroups.com
About this study
Official title: A Multicenter, Prospective, Randomized Controlled Modified Multi- Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
The purpose of this study is to evaluate the efficacy of human placental membrane products and standard of care versus standard of care alone in the management of nonhealing diabetic foot ulcers and venous leg ulcers.
Read the detailed description
This study is a multi-center, prospective, randomized controlled clinical study consisting of 650 subjects from up to 30 centers. The subjects are randomized to receive 1 of 4 treatments, either with Tri-Membrane Wrap™ (HPM-1); Membrane Wrap™ (HPM-2); Membrane Wrap-Lite™ (HPM-3); Membrane Wrap-Hydro™ (HPM-4); and SOC. The target ulcers are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of HPM-1 - HPM - 4 + SOC or SOC alone until or up to 12 weeks or until the study ulcer has completely closed (i.e. 100% closure as assessed by the investigator and confirmed 2 weeks later at the closure confirmation visit (CCV). One additional visit per week is optional for both arms, for the purpose of changing only (1) the secondary dressing in the HPM arm or (2) change the standard of care dressing in the control arm. A trial design diagram is found in Figure 3.
- Conditions
- Diabetic Foot, DFU, Diabetic Foot Ulcer, Foot Ulcer, Diabetic, Ulcer Foot, Venous Leg Ulcer
- Being tested
- Standard of Care DFU, Tri-Membrane Wrap™ DFU, Membrane Wrap™ DFU, Membrane Wrap-Lite™ DFU, Membrane Wrap-Hydro™ DFU
- Medical subject headings
- Diabetic Foot, Foot Ulcer, Varicose Ulcer, Leg Ulcer, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care DFUOther
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Tri-Membrane Wrap™ DFUOther
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.
Membrane Wrap™ DFUOther
Participants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Membrane Wrap-Lite™ DFUOther
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.
Membrane Wrap-Hydro™ DFUOther
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.
Standard of Care VLUOther
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and compression) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Tri-Membrane Wrap™ VLUOther
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.
Membrane Wrap™ VLUOther
Participants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Membrane Wrap-Lite™ VLUOther
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.
Membrane Wrap-Hydro™ VLUOther
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.
| Study group | Role | What they receive |
|---|---|---|
| DFU Standard of Care | Active comparator | Debridement, reduction of bacterial burden, and proper moisture balance using dressings. Off-loading using the off-loading boot or total contact cast (TCC). Receives: Other: Standard of Care DFU |
| DFU Tri-Membrane Wrap™ + SOC | Experimental | Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane. Receives: Other: Tri-Membrane Wrap™ DFU |
| DFU Membrane Wrap™ + SOC | Experimental | Membrane Wrap™ is an allograft derived from human amniotic membrane. Receives: Other: Membrane Wrap™ DFU |
| DFU Membrane Wrap-Lite™ + SOC | Experimental | Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane. Receives: Other: Membrane Wrap-Lite™ DFU |
| DFU Membrane Wrap-Hydro™ + SOC | Experimental | Membrane Wrap-Hydro™ is an allograft derived from human amniotic membrane. Receives: Other: Membrane Wrap-Hydro™ DFU |
| VLU Standard of Care | Active comparator | Debridement, reduction of bacterial burden, and proper moisture balance using dressings. Compression using multilayer compression wraps. Receives: Other: Standard of Care VLU |
| VLU Tri-Membrane Wrap™ + SOC | Experimental | Tri-Membrane Wrap™ is an allograft derived from human amniotic membrane. Receives: Other: Tri-Membrane Wrap™ VLU |
| VLU Membrane Wrap™ + SOC | Experimental | Membrane Wrap™ is an allograft derived from human amniotic membrane. Receives: Other: Membrane Wrap™ VLU |
| VLU Membrane Wrap-Lite™ + SOC | Experimental | Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane. Receives: Other: Membrane Wrap-Lite™ VLU |
| VLU Membrane Wrap-Hydro™ + SOC | Experimental | Membrane Wrap-Hydro™ is an allograft derived from human amniotic membrane. Receives: Other: Membrane Wrap-Hydro™ VLU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the between-arm difference percentage of subjects achieving complete closure of target ulcer over 12 weeks.
To determine the between-arm difference of multiple Human Placental Membrane (HPM) products plus SOC versus SOC alone in achieving complete closure of nonhealing diabetic foot ulcers and venous leg ulcers over 12 weeks using a modified dual platform (Matriarch) trial design. The initial plan is to evaluate several HPM per wound type; however, the modified platform design permits the inclusion of additional placental and umbilical cord derived products and can continue in perpetuity.
Measured: 1-12 Weeks
Secondary outcomes (7)
Time to Closure
To determine the between-arm difference in the time to closure over 12 weeks for HPM plus SOC versus SOC alone.
Measured: 1-12 weeks
Percent Area Reduction (PAR)
To determine the between-arm difference in the percent area reduction (PAR) at weekly intervals for HPM plus SOC versus SOC alone.
Measured: 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."
Measured: 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.
Measured: 1-12 weeks
Proportion of patients that reach complete closure over 65
To determine the proportion of ulcers that heal in patients 65 years or older for HPM plus SOC versus SOC alone.
Measured: 1-12 weeks
Functional Ambulatory Category Scale
To evaluate the between-arm difference in functional ambulation based on Functional Ambulatory Category Scale (FACS) - VLU subjects only. FACS is a scale from 0-5, 5 being completely independent and ambulatory on all surfaces.
Measured: 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."
Measured: 1-12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start15 Jul 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a multi-center, prospective, randomized controlled clinical study consisting of 650 subjects from up to 30 centers. The subjects are randomized to receive 1 of 4 treatments, either with Tri-Membrane Wrap™ (HPM-1); Membrane Wrap™ (HPM-2); Membrane Wrap-Lite™ (HPM-3); Membrane Wrap-Hydro™ (HPM-4); and SOC. The target ulcers are evaluated weekly by the investigator.
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioLab Holdings
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089602
- Sponsor's protocol ID
- BIOCAMP
- Acronym
- BIOCAMP
- Status last verified
- Jul 2025
- First submitted
- 30 Jun 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Controlled Modified Multi- Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT07089602
- Acronym / sponsor ID
- BIOCAMP / BIOCAMP
- Conditions
- Diabetic Foot, DFU, Diabetic Foot Ulcer, Foot Ulcer, Diabetic, Ulcer Foot, Venous Leg Ulcer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- BioLab HoldingsIndustry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of human placental membrane products and standard of care versus standard of care alone in the management of nonhealing diabetic foot ulcers and venous leg ulcers.
Detailed description
This study is a multi-center, prospective, randomized controlled clinical study consisting of 650 subjects from up to 30 centers. The subjects are randomized to receive 1 of 4 treatments, either with Tri-Membrane Wrap™ (HPM-1); Membrane Wrap™ (HPM-2); Membrane Wrap-Lite™ (HPM-3); Membrane Wrap-Hydro™ (HPM-4); and SOC. The target ulcers are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of HPM-1 - HPM - 4 + SOC or SOC alone until or up to 12 weeks or until the study ulcer has completely closed (i.e. 100% closure as assessed by the investigator and confirmed 2 weeks later at the closure confirmation visit (CCV). One additional visit per week is optional for both arms, for the purpose of changing only (1) the secondary dressing in the HPM arm or (2) change the standard of care dressing in the control arm. A trial design diagram is found in Figure 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
- Model description
- This study is a multi-center, prospective, randomized controlled clinical study consisting of 650 subjects from up to 30 centers. The subjects are randomized to receive 1 of 4 treatments, either with Tri-Membrane Wrap™ (HPM-1); Membrane Wrap™ (HPM-2); Membrane Wrap-Lite™ (HPM-3); Membrane Wrap-Hydro™ (HPM-4); and SOC. The target ulcers are evaluated weekly by the investigator.
| Arm | Type | Receives |
|---|---|---|
| DFU Standard of Care | Active comparator | Other: Standard of Care DFUDebridement, reduction of bacterial burden, and proper moisture balance using dressings. Off-loading using the off-loading boot or total contact cast (TCC). |
| DFU Tri-Membrane Wrap™ + SOC | Experimental | Other: Tri-Membrane Wrap™ DFUMembrane Wrap-Lite™ is an allograft derived from human amniotic membrane. |
| DFU Membrane Wrap™ + SOC | Experimental | Other: Membrane Wrap™ DFUMembrane Wrap™ is an allograft derived from human amniotic membrane. |
| DFU Membrane Wrap-Lite™ + SOC | Experimental | Other: Membrane Wrap-Lite™ DFUMembrane Wrap-Lite™ is an allograft derived from human amniotic membrane. |
| DFU Membrane Wrap-Hydro™ + SOC | Experimental | Other: Membrane Wrap-Hydro™ DFUMembrane Wrap-Hydro™ is an allograft derived from human amniotic membrane. |
| VLU Standard of Care | Active comparator | Other: Standard of Care VLUDebridement, reduction of bacterial burden, and proper moisture balance using dressings. Compression using multilayer compression wraps. |
| VLU Tri-Membrane Wrap™ + SOC | Experimental | Other: Tri-Membrane Wrap™ VLUTri-Membrane Wrap™ is an allograft derived from human amniotic membrane. |
| VLU Membrane Wrap™ + SOC | Experimental | Other: Membrane Wrap™ VLUMembrane Wrap™ is an allograft derived from human amniotic membrane. |
| VLU Membrane Wrap-Lite™ + SOC | Experimental | Other: Membrane Wrap-Lite™ VLUMembrane Wrap-Lite™ is an allograft derived from human amniotic membrane. |
| VLU Membrane Wrap-Hydro™ + SOC | Experimental | Other: Membrane Wrap-Hydro™ VLUMembrane Wrap-Hydro™ is an allograft derived from human amniotic membrane. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- The potential subject must be at least 18 years of age or older.
- The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.
- At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20 cm2 measured post debridement with the eKare inSight® imaging device.
- The potential subject must have a target ulcer that has been present for a minimum of 4 weeks of standard of care, prior to the initial screening visit.
- The potential subject must have a target ulcer located on the foot with at least 50% of the ulcer below the malleolus.
Key exclusion criteria (37 listed)
- The potential subject is known to have a life expectancy of < 6 months.
- The potential subject's target ulcer is not secondary to diabetes.
- The target ulcer is infected or there is cellulitis in the surrounding skin.
- The target ulcer exposes tendon or bone.
- There is evidence of osteomyelitis complicating the target ulcer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care DFUBeginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | DFU Standard of Care |
| Tri-Membrane Wrap™ DFUParticipants will receive weekly applications of Tri-Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | DFU Tri-Membrane Wrap™ + SOC |
| Membrane Wrap™ DFUParticipants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | DFU Membrane Wrap™ + SOC |
| Membrane Wrap-Lite™ DFUParticipants will receive weekly applications of Membrane Wrap-Lite™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | DFU Membrane Wrap-Lite™ + SOC |
| Membrane Wrap-Hydro™ DFUParticipants will receive weekly applications of Membrane Wrap-Hydro™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | DFU Membrane Wrap-Hydro™ + SOC |
| Standard of Care VLUBeginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and compression) until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | VLU Standard of Care |
| Tri-Membrane Wrap™ VLUParticipants will receive weekly applications of Tri-Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | VLU Tri-Membrane Wrap™ + SOC |
| Membrane Wrap™ VLUParticipants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | VLU Membrane Wrap™ + SOC |
| Membrane Wrap-Lite™ VLUParticipants will receive weekly applications of Membrane Wrap-Lite™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | VLU Membrane Wrap-Lite™ + SOC |
| Membrane Wrap-Hydro™ VLUParticipants will receive weekly applications of Membrane Wrap-Hydro™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | VLU Membrane Wrap-Hydro™ + SOC |
Primary outcome
Determine the between-arm difference percentage of subjects achieving complete closure of target ulcer over 12 weeks.
Time frame: 1-12 Weeks
To determine the between-arm difference of multiple Human Placental Membrane (HPM) products plus SOC versus SOC alone in achieving complete closure of nonhealing diabetic foot ulcers and venous leg ulcers over 12 weeks using a modified dual platform (Matriarch) trial design. The initial plan is to evaluate several HPM per wound type; however, the modified platform design permits the inclusion of additional placental and umbilical cord derived products and can continue in perpetuity.
7 secondary outcomes
Time to Closure
Time frame: 1-12 weeks
Percent Area Reduction (PAR)
Time frame: 1-12 weeks
Determine improvement in quality of life
Time frame: 1-12 Weeks
Pain in patients who present with VAS greater than 4
Time frame: 1-12 weeks
Proportion of patients that reach complete closure over 65
Time frame: 1-12 weeks
Functional Ambulatory Category Scale
Time frame: 1-12 Weeks
Determine improvement in quality of life
Time frame: 1-12 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tri-Membrane Wrap™ DFU, Membrane Wrap™ DFU and Membrane Wrap-Lite™ DFU in people with Diabetic Foot and DFU, run by BioLab Holdings at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bennett Sarver (888-960-1343 ext. 1008, bsarver@serenagroups.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the between-arm difference percentage of subjects achieving complete closure of target ulcer over 12 weeks. (time frame: 1-12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.