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

Part of paid clinical trials in Hollywood, Florida.

Sponsor
Applied Biologics, LLC
Study ID
NCT07159282
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • DFU
  • Diabetic Foot
  • Diabetic Foot Ulcer
  • Foot Ulcer
  • Foot Ulcer Due to Type 1 Diabetes Mellitus
  • Foot Ulcer Due to Type 2 Diabetes Mellitus
  • Ulcer Foot

Eligibility Criteria

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

Interventions

  • XWRAP — OTHER
    Application of XWRAP + standard of care for up to 12 weeks.

Study Details

A multicenter, prospective, controlled clinical trial evaluating the efficacy of a single layer placental-based allograft and standard of care in the management of nonhealing diabetic foot ulcers.

Key Dates

Start date
Aug 26, 2025
Status verified
Aug 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: XWRAP
    Single-layer amniotic membrane + standard of care.

Primary Outcome Measure

Wound Closure [ Time Frame: 1-12 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Royal ResearchHollywoodFlorida33024
Yaliliy Perez
[email protected]
954-940-0208

Find similar trials in Hollywood, FL

By research site
Royal Research· Hollywood, FL

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