Efficacy of Human Placental Graft in Diabetic Foot Ulcers

June 28, 2024 updated by: StimLabs

A Clinical Investigation Into the Efficacy of Full-thickness Human Placental Graft (Revita) in Diabetic Foot Ulcers

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Pensacola, Florida, United States, 32503
        • Gulf Coast Podiatry
    • Louisiana
      • Lake Charles, Louisiana, United States, 70605
        • Louisiana Foot and Ankle Specialists
    • Pennsylvania
      • Springfield, Pennsylvania, United States, 19064
        • Crozer/Keystone Health System, Center for Wound Healing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Treatment
Will receive Revita allograft for wound treatment
Other: Revita Allograft
Human placental allograft
No Intervention: Control
Will receive current standard of care for wound treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Wound Closure
Time Frame: 12 weeks
100% epithelization
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent(%) Healed
Time Frame: 12 weeks
Percentage of wound healed
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

StimLabs

Investigators

  • Study Director: Clinical Research Manager, StimLabs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2018

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

October 12, 2018

First Submitted That Met QC Criteria

October 12, 2018

First Posted (Actual)

October 16, 2018

Study Record Updates

Last Update Posted (Actual)

July 1, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLRV-POD-WC-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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