Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care

Part of paid clinical trials in Clinton Township, Michigan.

Sponsor
Applied Biologics, LLC
Study ID
NCT06564831
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SLAM + SOC — OTHER
    Weekly Treatment visits for 12 weeks begin at day 0. SLAM applications with SOC until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
  • SOC — 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.

Study Details

A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care versus Standard of Care alone in the management of Nonhealing Diabetic Foot Ulcers

Key Dates

Start date
Sep 20, 2024
Status verified
Nov 2024
Primary completion
Feb 28, 2025
Completion
Aug 31, 2025

Study Design

Enrollment
124 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of Care
    Other: Standard of Care Standard of care will be cleaning, debridement, ulcer moisture balance, and offloading.
  • Experimental: SLAM + SOC
    Single layer amniotic membrane (SLAM) + SOC

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Detroit Foot and AnkleClinton TownshipMichigan48038
Lina Barman
[email protected]
586-329-3895
(586) 329-3895

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Detroit Foot and Ankle· Clinton Township, MI

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