A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of Multiple Human Placental-Based Skin Substitutes and Standard of Care Versus SOC Alone in the Treatment of Hard-to-Heal Diabetic Foot Ulcers

Summary

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.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Other
  Standard of Care

  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.

• Other
  Revita

  Participants will receive weekly applications of Revita and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

• Other
  Relese

  Participants will receive weekly applications of Relese and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

• Other
  Cogenex

  Participants will receive weekly applications of Cogenex and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

• Other
  Enverse

  Participants will receive weekly applications of Enverse and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Locations (5)