Skin Substitutes + Standard Care for Diabetic Foot Ulcers

(CAMPSTIM Trial)

Recruiting at 4 trial locations

Overseen By Thomas Serena, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: StimLabs

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

Disqualifiers: Infection, Osteomyelitis, Charcot foot, others

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

Compensation: Varies

Number of Visits: 14

Duration: 12 weeks

272 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding skin substitutes to standard care can more effectively heal stubborn diabetic foot ulcers. Researchers will compare four different skin substitute treatments—Cogenex, Enverse, Relese, and Revita—alongside usual care, such as cleaning and protective measures. Individuals with diabetes who have a foot ulcer persisting for 4 to 52 weeks and not healing well may be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could enhance healing for diabetic foot ulcers.

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, as these may interfere with wound healing.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that treatments using dehydrated human placental membrane (dCHPM) allografts, such as Revita, Relese, Cogenex, and Enverse, are generally safe for treating chronic wounds. Studies have found no reports of negative side effects with these treatments, indicating they are well-tolerated by patients. These placenta-based materials have proven more effective than standard treatments in healing ulcers. While the evidence is strong, discussing any concerns with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they use dehydrated complete human placental membrane (dCHPM) allografts, which offer a unique approach to healing diabetic foot ulcers. Unlike traditional methods that focus on cleaning, debridement, and moisture balance, these treatments—Revita, Relese, Cogenex, and Enverse—provide a biological scaffold that can potentially enhance the body's own healing process. Each of these treatments has distinct characteristics: Revita is opaque, Relese and Cogenex are fenestrated, and Enverse is translucent, allowing researchers to explore which properties might be most effective in promoting ulcer healing. This innovative use of human placental tissue offers a promising new direction for faster and more effective healing in patients with diabetic foot ulcers.

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

Research has shown that treatments using dehydrated human placental membrane (dHPM) can accelerate the healing of diabetic foot ulcers. In one study, 94.4% of wounds treated with similar products remained healed after 9 to 12 months. Another study found that placenta-based treatments were more effective at fully healing ulcers than standard care. These treatments use natural materials from the placenta to enhance the body's ability to repair and close wounds. In this trial, participants will receive either standard care or one of the experimental treatments: Revita, Relese, Cogenex, or Enverse. Early results suggest these products may improve healing for those with difficult-to-heal foot ulcers. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with hard-to-heal diabetic foot ulcers. Participants should meet specific health criteria to be eligible, but the provided information does not detail these requirements.

Inclusion Criteria

My foot ulcer is mostly below my ankle.

Blood flow in my affected limb is confirmed to be good.

My foot ulcer has been pressure-free for at least 2 weeks.

Exclusion Criteria

I am currently on antibiotics for an infection.

Known life expectancy of < 6 months

My ulcer exposes tendon or bone.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of the four dehydrated complete human placental membrane products or standard of care for diabetic foot ulcers

12 weeks

13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cogenex
• Enverse
• Relese
• Revita
• Standard of Care

Trial Overview The study tests the effectiveness of four skin substitutes (Enverse, Cogenex, Revita, Relese) plus standard wound care against just standard wound care in healing diabetic foot ulcers over a period of 12 weeks.

How Is the Trial Designed?

Group I: Revita Experimental Treatment 1 Intervention

Revita is an opaque, lyophilized dehydrated complete human placental membrane (dCHPM) allograft.

Group II: Relese Experimental Treatment 1 Intervention

Relese is a fenestrated dehydrated complete human placental membrane (dCHPM) allograft.

Group III: Enverse Experimental Treatment 1 Intervention

Enverse is a translucent dehydrated complete human placental membrane (dCHPM) allograft.

Group IV: Cogenex Experimental Treatment 1 Intervention

Cognenex is a fenestrated dehydrated complete human placental membrane (dCHPM) allograft.

Group V: Standard of Care Active Control 1 Intervention

Standard of care will be cleaning, debridement, ulcer moisture balance, and offloading.

Cogenex is already approved in United States for the following indications:

Approved in United States as Cogenex for:

• Diabetic Foot Ulcers

Who Is Running the Clinical Trial?

StimLabs

Lead Sponsor

Trials

4

Recruited

360+

SerenaGroup, Inc.

Collaborator

Trials

32

Recruited

3,900+

Published Research Related to This Trial

The dehydrated complete human placental membrane (dCHPM) allograft retains most of the beneficial matrix structures and regulatory proteins found in native placental membranes, making it a promising option for chronic wound treatment.

The intermediate layer (IL) of the placental membrane contains over 900 regulatory proteins that play crucial roles in various healing processes, suggesting that maintaining the entire intact placental membrane, including the IL, could enhance the effectiveness of wound healing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermediate layer contribution in placental membrane allografts. Roy, A., Griffiths, S.[2021]

Decellularized, dehydrated human amniotic membrane (DDHAM) effectively supports the attachment and proliferation of human dermal fibroblasts and epithelial keratinocytes, unlike the dehydrated human amnion/chorion membrane (dHACM).

Cells cultured on DDHAM release soluble factors that enhance the survival and migration of endothelial cells, indicating that DDHAM not only serves as a scaffold but also promotes important cellular responses beneficial for wound healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of Cell Attachment, Proliferation, and Angiogenesis by Decellularized, Dehydrated Human Amniotic Membrane in In Vitro Models. Guo, X., Kaplunovsky, A., Zaka, R., et al.[2022]

In an open-label extension phase of a clinical trial involving 26 patients with chronic diabetic foot ulcers, 65.4% of patients achieved wound closure after receiving weekly applications of cryopreserved placental membrane (CPM) over a median of 34 days.

The use of CPM resulted in significantly fewer adverse events and wound-related infections compared to standard wound care, supporting its safety and efficacy as a treatment option for chronic diabetic foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open-label Extension Phase of a Chronic Diabetic Foot Ulcer Multicenter, Controlled, Randomized Clinical Trial Using Cryopreserved Placental Membrane. Lavery, L., Fulmer, J., Shebetka, KA., et al.[2019]

In a case series of 3 patients with chronic ulcers that did not respond to standard treatments, viable cryopreserved human placental membrane (vCHPM) led to full closure of a pressure ulcer and an arterial ulcer within 4 to 5 weeks, demonstrating its efficacy.

The treatment showed promising results for a pyoderma gangrenosum ulcer as well, achieving 64% closure after 9 applications, highlighting the potential of vCHPM for various types of chronic wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of Viable Cryopreserved Human Placental Membrane Grafts in the Treatment of Wounds of Diverse Etiologies: A Case Series. Anselmo, DS., McGuire, JB., Love, E., et al.[2018]

In a case series of five patients with chronic non-healing wounds, the use of dehydrated human amnion/chorion membrane allograft resulted in a significant mean area reduction of 43% at 3 weeks, with complete healing achieved in a median time of 64 days.

The treatment was safe, with no adverse events reported, and was easy to administer, indicating that dehydrated amnion/chorion membrane allograft could be an effective option for patients whose wounds have not responded to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amniotic membrane is a potential regenerative option for chronic non-healing wounds: a report of five cases receiving dehydrated human amnion/chorion membrane allograft. Mrugala, A., Sui, A., Plummer, M., et al.[2021]

In a study of 79 patients with 101 wounds, the use of viable intact cryopreserved human placental membrane (vCPM) resulted in a significantly higher rate of complete wound closure (63.0%) compared to dehydrated human amnion/chorion membrane (dHACM) which had a closure rate of only 18.2% (p < 0.0001).

This research is the first to compare the clinical effectiveness of different placental wound care products in a real-world setting, highlighting the superior performance of vCPM for wound management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative outcomes analysis evaluating clinical effectiveness in two different human placental membrane products for wound management. Johnson, EL., Marshall, JT., Michael, GM.[2022]

The uniquely folded dehydrated binate amniotic membrane (DBAM) is confirmed to be chorion-free and retains an epithelial cell layer, which is important for its potential use in wound healing.

DBAM contains cytokines that promote the proliferation and migration of bone marrow stromal and stem cells, suggesting it could effectively stimulate tissue regeneration in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biochemical characterization of pure dehydrated binate amniotic membrane: role of cytokines in the spotlight. Sane, MS., Misra, N., Quintanar, NM., et al.[2018]

In a study involving 29 adults with diabetes and chronic foot ulcers, the use of dehydrated amniotic membrane allograft (DAMA) combined with standard care led to a significant increase in complete wound closure rates, with 35% achieving closure compared to 0% in the standard care group within 6 weeks.

No treatment-related adverse events were reported, indicating that DAMA is a safe option for managing diabetic foot ulcers, although further research is necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective, Randomized, Multicenter, Controlled Evaluation of the Use of Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcer. Snyder, RJ., Shimozaki, K., Tallis, A., et al.[2017]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06449638

Modified Platform Trial Assessing Multiple CAMPs and ... The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, also defined as Cellular, Acellular, Matrix-like ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06449638?cond=%22Foot%20Ulcer%22&viewType=Table&rank=5

Modified Platform Trial Assessing Multiple CAMPs and ... The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, also defined as Cellular, Acellular, Matrix-like ...

3. researchgate.net researchgate.net/publication/397066185_Evaluation_of_human_placental-based_cellular_acellular_and_matrix-like_products_CAMPs_in_the_management_of_nonhealing_diabetic_foot_ulcers_an_interim_analysis_of_the_CAMPSTIM_clinical_trial

an interim analysis of the CAMPSTIM clinical trial Evaluation of human placental-based cellular, acellular and matrix-like products (CAMPs) in the management of nonhealing diabetic foot ...

4. withpower.com withpower.com/trial/phase-foot-ulcer-5-2024-6b25f

Skin Substitutes + Standard Care for Diabetic Foot Ulcers The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, also defined as Cellular, Acellular, Matrix-like ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11183911/

Assessing placental membrane treatment efficiency in ... The findings suggest that while L‐AC might be slightly more effective in complete ulcer healing, RE‐AC offers overall better treatment efficiency.

6. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=39865

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 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1871402124002315

Placenta-derived biomaterials vs. standard care in chronic ... Placenta-derived biomaterials therapies have been shown to be more effective for achieving complete ulcer healing compared to current conventional treatments ...