Efficacy of Human Placental Graft in Diabetic Foot Ulcers

Last updated: June 28, 2024
Sponsor: StimLabs
Overall Status: Terminated

Phase

N/A

Condition

Diabetes And Hypertension

Ulcers

Treatment

Revita Allograft

Clinical Study ID

NCT03708029
SLRV-POD-WC-001
  • Ages 18-80
  • All Genders

Study Summary

To determine the efficacy of full-thickness placental allograft in chronic wound healing

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female patients

  • 18-80 years old

  • Diagnosis of Type 1 or 2 Diabetes Mellitus

  • Foot ulcers >1cm2 and <25cm2 for 4 weeks or more prior to enrollment

  • Able to give consent to participate

  • Compliance with all aspects of protocol and follow-up

Exclusion

Exclusion Criteria:

  • Male and female patients younger than 18 years old

  • Male or female patients older than 80 years old

  • Smoking, and any additional health risk factors contraindicated with Revita use

  • Involvement in any other ongoing studies

Study Design

Total Participants: 9
Treatment Group(s): 1
Primary Treatment: Revita Allograft
Phase:
Study Start date:
November 13, 2018
Estimated Completion Date:
December 01, 2019

Study Description

To evaluate the efficacy of Revita full thickness placental allograft in improving wound closure rates and mean closure time in diabetic foot ulcers (DFUs) as compared to the current standards of wound care treatment

Connect with a study center

  • Gulf Coast Podiatry

    Pensacola, Florida 32503
    United States

    Site Not Available

  • Louisiana Foot and Ankle Specialists

    Lake Charles, Louisiana 70605
    United States

    Site Not Available

  • Crozer/Keystone Health System, Center for Wound Healing

    Springfield, Pennsylvania 19064
    United States

    Site Not Available

  • Springfield Hospital - Center for Wound Healing

    Springfield, Pennsylvania 19064
    United States

    Active - Recruiting

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