A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Evaluating Placental Derived Allografts and Standard of Care in the Treatment of Nonhealing Diabetic Foot Ulcers Using Matched Controls

Summary

The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Other
  Activate™ Matrix

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

• Other
  AmnioDefend™ FT Matrix

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

• Other
  Palisade™ DM Matrix

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

• Other
  Enclose™ TL Matrix

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

• Other
  Sentry™ SL Matrix

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

Location