Placental Membrane Products for Diabetic Foot and Venous Leg Ulcers

(BIOCAMP Trial)

Overseen By Thomas Serena

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: BioLab Holdings

Must not be taking: Immunosuppressants, Chemotherapy, Hydroxyurea, Biologics

Disqualifiers: Pregnancy, Renal disease, Osteomyelitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

650 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether products made from human placental membranes can heal stubborn diabetic foot ulcers and venous leg ulcers more effectively than usual treatments. Participants will receive either the placental membrane treatment with standard care or just standard care to determine which is more effective. The study seeks individuals with diabetes who have had a foot ulcer for at least four weeks that has not healed with regular care. As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking immunosuppressants, certain chemotherapy drugs, or hydroxyurea. It's best to discuss your specific medications with the trial team.

What is the safety track record for human placental membrane products?

Research has shown that products made from the human placental membrane are generally safe for treating diabetic foot ulcers and venous leg ulcers. These products derive from the amniotic membrane, a part of the placenta. Studies have evaluated their wound-healing effectiveness, and safety information also comes from their use in other conditions.

Ongoing clinical studies and real-world applications suggest this treatment is generally safe. However, like any treatment, side effects can occur. Mild skin irritation is sometimes reported, but serious issues are rare.

Since this study is in a later phase, it indicates the treatment has been tested on many people and is considered safe enough for wider use. Those considering joining a trial should discuss potential risks with their healthcare provider. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because they use human placental membrane products, a unique approach compared to the standard of care for diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). Unlike traditional methods that focus on debridement, moisture balance, and compression, these experimental treatments employ allografts derived from human amniotic membrane. This innovative material is known for its regenerative properties, potentially enhancing wound healing and tissue repair. By leveraging the natural growth factors and anti-inflammatory benefits found in placental membranes, these treatments might offer quicker and more effective healing options for patients with chronic ulcers.

What evidence suggests that this trial's treatments could be effective for diabetic foot and venous leg ulcers?

Earlier studies have shown that products made from the human placental membrane hold promise for treating stubborn diabetic foot ulcers (DFU) and venous leg ulcers (VLU). Research indicates that up to 70% of wounds treated with these membranes healed, compared to only 7.1% with standard care alone. In this trial, participants will receive different versions of these membrane products, such as Membrane Wrap™, Membrane Wrap-Lite™, and Membrane Wrap-Hydro™, combined with standard care. These products, derived from the amniotic membrane, help reduce swelling and support healing by creating a protective layer and providing essential nutrients to the wound. Clinical consensus also supports this treatment as effective for similar long-lasting wounds. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with nonhealing diabetic foot ulcers or venous leg ulcers. Participants should be adults who have had an ulcer for a certain period without healing, and are able to follow the study procedures. Specific details about inclusion and exclusion criteria were not provided.

Inclusion Criteria

I have more than one ulcer, and they are at least 2 cm apart.

The potential subject must be willing and able to participate in the informed consent process.

My ulcer has not healed after 4 weeks of standard treatment.

Exclusion Criteria

The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.

The potential subject has a malnutrition indicator score less than 17 as measured on the Mini Nutritional Assessment.

The potential subject is known to have a life expectancy of less than 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly applications of HPM products or SOC alone until 12 weeks or complete ulcer closure

12 weeks

Weekly visits (in-person)

Closure Confirmation

Ulcer closure is confirmed 2 weeks after initial assessment of 100% closure

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Human Placental Membrane Products

Trial Overview The study is testing if adding human placental membrane products to the usual wound care (standard of care) helps heal diabetic foot and venous leg ulcers better than standard treatment alone.

How Is the Trial Designed?

Group I: VLU Tri-Membrane Wrap™ + SOC Experimental Treatment 1 Intervention

Tri-Membrane Wrap™ is an allograft derived from human amniotic membrane.

Group II: VLU Membrane Wrap™ + SOC Experimental Treatment 1 Intervention

Membrane Wrap™ is an allograft derived from human amniotic membrane.

Group III: VLU Membrane Wrap-Lite™ + SOC Experimental Treatment 1 Intervention

Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane.

Group IV: VLU Membrane Wrap-Hydro™ + SOC Experimental Treatment 1 Intervention

Membrane Wrap-Hydro™ is an allograft derived from human amniotic membrane.

Group V: DFU Tri-Membrane Wrap™ + SOC Experimental Treatment 1 Intervention

Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane.

Group VI: DFU Membrane Wrap™ + SOC Experimental Treatment 1 Intervention

Membrane Wrap™ is an allograft derived from human amniotic membrane.

Group VII: DFU Membrane Wrap-Lite™ + SOC Experimental Treatment 1 Intervention

Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane.

Group VIII: DFU Membrane Wrap-Hydro™ + SOC Experimental Treatment 1 Intervention

Membrane Wrap-Hydro™ is an allograft derived from human amniotic membrane.

Group IX: VLU Standard of Care Active Control 1 Intervention

Debridement, reduction of bacterial burden, and proper moisture balance using dressings. Compression using multilayer compression wraps.

Group X: DFU Standard of Care Active Control 1 Intervention

Debridement, reduction of bacterial burden, and proper moisture balance using dressings. Off-loading using the off-loading boot or total contact cast (TCC).

Who Is Running the Clinical Trial?

BioLab Holdings

Lead Sponsor

Trials

1

Recruited

380+

SerenaGroup, Inc.

Collaborator

Trials

32

Recruited

3,900+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07089602

Trial Assessing the Efficacy of Human Placental Membrane ... 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07078968?aggFilters=status:act,funderType:industry&viewType=Table&rank=3

Study Details | NCT07078968 | A REAL WORLD DATA ... This study is designed to evaluate the effectiveness of Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ compared to the ...

3. evtoday.com evtoday.com/news/biolab-amnion-grafts-for-chronic-wounds-to-be-studied-in-amnioheal-rwe-trial

BioLab Amnion Grafts for Chronic Wounds to Be Studied in ... Patients in the study will receive either the Tri-Membrane Wrap or Membrane Wrap-Lite in addition to SOC. Outcomes will be compared to the ...

4. ctv.veeva.com ctv.veeva.com/study/trial-assessing-the-efficacy-of-human-placental-membrane-products-and-standard-of-care-versus-standa

Trial Assessing the Efficacy of Human Placental Membrane ... 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 ...

5. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39864&ver=2

Skin Substitute Grafts/Cellular and Tissue-Based Products ... This LCD covers skin substitute grafts/cellular and tissue-based products (CTP) for the treatment of diabetic foot ulcers (DFU) and venous leg ulcers (VLU) in ...

6. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=36377

LCD - Skin Substitute Grafts/Cellular and Tissue-Based ... This LCD covers skin substitute grafts/cellular and tissue-based products (CTP) for the treatment of diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) in ...

7. uhcprovider.com uhcprovider.com/content/dam/provider/docs/public/policies/comm-medical-drug/skin-soft-tissue-substitutes.pdf

Skin and Soft Tissue Substitutes Diabetes was the primary cause of the ulcer. The ulcers had a mean size of. 4.3 cm2 in the standard care group and 3.6 cm2 in the amniotic ...

8. morningstar.com morningstar.com/news/pr-newswire/20251029la09743/biolab-holdings-inc-announces-multiple-clinical-trials-to-advance-chronic-wound-care

BioLab Holdings Inc. Announces Multiple Clinical Trials to ... BioLab is also conducting a real-world data collection trial evaluating human amniotic membrane(s) on diabetic foot ulcers, venous leg ulcers, ...