ClinicalTrials.gg
TerminatedNCT03708029Updated Jul 1, 2024

Efficacy of Human Placental Graft in Diabetic Foot Ulcers

An interventional study of Revita Allograft in Diabetic Foot, sponsored by StimLabs. Terminated at 3 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-01.

Sponsored by StimLabs · Not applicable, Interventional, and Treatment

Why this study was terminated
Low enrollment.
Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Diabetic Foot

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03

In context

Diabetic Foot

1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's enrollment of 9 is below the median of 60 across 847 interventional studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

StimLabs is the lead sponsor of 8 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 with Revita use
  • Involvement in any other ongoing studies
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Intervention Treatment

    Will receive Revita allograft for wound treatment

    Other: Revita Allograft

  • No intervention
    Control

    Will receive current standard of care for wound treatment

Interventions

  • OtherRevita Allograft

    Human placental allograft

06

What researchers measure

Primary outcomes

  1. Complete Wound Closure

    100% epithelization

    Time frame: 12 weeks

Secondary outcomes

  1. Percent(%) Healed

    Percentage of wound healed

    Time frame: 12 weeks

07

Study locations

3 sites
  • Gulf Coast Podiatry
    Pensacola, Florida 32503, United States
  • Louisiana Foot and Ankle Specialists
    Lake Charles, Louisiana 70605, United States
  • Crozer/Keystone Health System, Center for Wound Healing
    Springfield, Pennsylvania 19064, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03708029
Lead sponsor
StimLabs
Responsible party
Sponsor
First posted
Oct 16, 2018
Start date
Nov 13, 2018
Primary completion
Dec 1, 2019
Completion
Dec 1, 2019
Last update
Jul 1, 2024

Study contacts

Clinical Research Manager
study director · StimLabs

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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