Skin Substitutes + Standard Care for Diabetic Foot Ulcers
(CAMPSTIM Trial)
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?
What makes the treatment with Cogenex, Enverse, Relese, and Revita unique for diabetic foot ulcers?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive one of the four dehydrated complete human placental membrane products or standard of care for diabetic foot ulcers
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cogenex
- Enverse
- Relese
- Revita
- Standard of Care
Cogenex is already approved in United States for the following indications:
- Diabetic Foot Ulcers
Find a Clinic Near You
Who Is Running the Clinical Trial?
StimLabs
Lead Sponsor
SerenaGroup, Inc.
Collaborator