NCT03708029

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

November 13, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

October 12, 2018

Last Update Submit

June 28, 2024

Conditions

Diabetic Foot

Outcome Measures

Primary Outcomes (1)

  • Complete Wound Closure

    100% epithelization

    12 weeks

Secondary Outcomes (1)

  • Percent(%) Healed

    12 weeks

Study Arms (2)

Intervention Treatment

EXPERIMENTAL

Will receive Revita allograft for wound treatment

Other: Revita Allograft

Control

NO INTERVENTION

Will receive current standard of care for wound treatment

Interventions

Revita AllograftOTHER

Human placental allograft

Intervention Treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Gulf Coast Podiatry

Pensacola, Florida, 32503, United States

Location

Louisiana Foot and Ankle Specialists

Lake Charles, Louisiana, 70605, United States

Location

Crozer/Keystone Health System, Center for Wound Healing

Springfield, Pennsylvania, 19064, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Clinical Research Manager

    StimLabs

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2018

First Posted

October 16, 2018

Study Start

November 13, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

July 1, 2024

Record last verified: 2024-06

Locations

US(3)