Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs

Conditions

• Diabetic Foot
• Diabetic Foot Ulcer (DFU)
• Foot Ulcer
• Ulcer Foot

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Standard of Care — OTHER
  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.
• Revita — OTHER
  Participants will receive weekly applications of Revita and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
• Relese — OTHER
  Participants will receive weekly applications of Relese and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
• Cogenex — OTHER
  Participants will receive weekly applications of Cogenex and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
• Enverse — OTHER
  Participants will receive weekly applications of Enverse and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Study Details

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.

Key Dates

Start date

Jul 16, 2024

Status verified

Feb 2026

Primary completion

Nov 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

272 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Standard of Care
  Standard of care will be cleaning, debridement, ulcer moisture balance, and offloading.
• Experimental: Revita
  Revita is an opaque, lyophilized dehydrated complete human placental membrane (dCHPM) allograft.
• Experimental: Relese
  Relese is a fenestrated dehydrated complete human placental membrane (dCHPM) allograft.
• Experimental: Cogenex
  Cognenex is a fenestrated dehydrated complete human placental membrane (dCHPM) allograft.
• Experimental: Enverse
  Enverse is a translucent dehydrated complete human placental membrane (dCHPM) allograft.

Primary Outcome Measure

The percentage of target ulcers achieving complete wound closure [ Time Frame: 1-12 weeks ]

Central Contacts

• Kristy Breisinger
  888-960-1343
  [email protected]
• Thomas Serena, MD
  814-688-4000
  [email protected]

Locations (5)

Find similar trials in Omaha, NE

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