272 Participants Needed

Skin Substitutes + Standard Care for Diabetic Foot Ulcers

(CAMPSTIM Trial)

Recruiting at 4 trial locations
KB
TS
Overseen ByThomas Serena, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal diabetic foot ulcers over 12 weeks using a modified platform trial design.

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.

What data supports the effectiveness of the treatment Cogenex, Enverse, Relese, and Revita for diabetic foot ulcers?

Research shows that dehydrated human placental membrane allografts, like those used in Cogenex, Enverse, Relese, and Revita, contain important proteins that help with wound healing. In a study, patients with chronic wounds treated with similar placental membrane products experienced significant wound area reduction and complete healing over time, suggesting these treatments can be effective for non-healing wounds.12345

Is the use of dehydrated human placental membrane allografts safe for treating wounds?

Research indicates that dehydrated human placental membrane allografts are generally safe for treating chronic non-healing wounds, with no adverse events reported in a case series of five patients.12345

What makes the treatment with Cogenex, Enverse, Relese, and Revita unique for diabetic foot ulcers?

This treatment uses dehydrated human placental membrane, which is unique because it provides a natural scaffold that supports wound healing by promoting cell attachment and growth, potentially accelerating the closure of diabetic foot ulcers compared to standard care alone.34678

Eligibility Criteria

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.
See 8 more

Exclusion Criteria

I am currently on antibiotics for an infection.
Known life expectancy of < 6 months
My ulcer exposes tendon or bone.
See 16 more

Timeline

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)

Treatment Details

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.
Participant Groups
5Treatment groups
Experimental Treatment
Active Control
Group I: RevitaExperimental Treatment1 Intervention
Revita is an opaque, lyophilized dehydrated complete human placental membrane (dCHPM) allograft.
Group II: ReleseExperimental Treatment1 Intervention
Relese is a fenestrated dehydrated complete human placental membrane (dCHPM) allograft.
Group III: EnverseExperimental Treatment1 Intervention
Enverse is a translucent dehydrated complete human placental membrane (dCHPM) allograft.
Group IV: CogenexExperimental Treatment1 Intervention
Cognenex is a fenestrated dehydrated complete human placental membrane (dCHPM) allograft.
Group V: Standard of CareActive Control1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

StimLabs

Lead Sponsor

Trials
4
Recruited
360+

SerenaGroup, Inc.

Collaborator

Trials
32
Recruited
3,900+

Findings from Research

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.
Intermediate layer contribution in placental membrane allografts.Roy, A., Griffiths, S.[2021]
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.
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]
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.
Biochemical characterization of pure dehydrated binate amniotic membrane: role of cytokines in the spotlight.Sane, MS., Misra, N., Quintanar, NM., et al.[2018]

References

Intermediate layer contribution in placental membrane allografts. [2021]
Amniotic membrane is a potential regenerative option for chronic non-healing wounds: a report of five cases receiving dehydrated human amnion/chorion membrane allograft. [2021]
Biochemical characterization of pure dehydrated binate amniotic membrane: role of cytokines in the spotlight. [2018]
Modulation of Cell Attachment, Proliferation, and Angiogenesis by Decellularized, Dehydrated Human Amniotic Membrane in In Vitro Models. [2022]
A comparative outcomes analysis evaluating clinical effectiveness in two different human placental membrane products for wound management. [2022]
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. [2017]
Application of Viable Cryopreserved Human Placental Membrane Grafts in the Treatment of Wounds of Diverse Etiologies: A Case Series. [2018]
Open-label Extension Phase of a Chronic Diabetic Foot Ulcer Multicenter, Controlled, Randomized Clinical Trial Using Cryopreserved Placental Membrane. [2019]
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