Efficacy of Human Placental Graft in Diabetic Foot Ulcers | NCT03708029

Studies
Efficacy of Human Placental Graft in Diabetic Foot Ulcers

NCT03708029

Sponsor

StimLabs

Status

Terminated

Last Update Posted

Jul 1, 2024Actual

Enrollment

9Actual

Phase

Not Applicable

Conditions

Diabetic Foot

Interventions

Revita Allograft

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low enrollment.

Expanded Access Info

Start Date

Nov 13, 2018Actual

Primary Completion Date

Dec 1, 2019Actual

Completion Date

Dec 1, 2019Actual

First Submitted Date

Oct 12, 2018

First Submission Date that Met QC Criteria

Oct 12, 2018

First Posted Date

Oct 16, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2024

Last Update Posted Date

Jul 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Revita Allograft	Other	Human placental allograft	Intervention Treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Research Manager	StimLabs	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gulf Coast Podiatry		Pensacola	Florida	32503	United States
Louisiana Foot and Ankle Specialists

Condition Browse Module

MeSH Terms

ID	Term
D017719	Diabetic Foot

Ancestor Terms

ID	Term
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016523	Foot Ulcer

Browse Leaves

Not provided

Browse Branches

Not provided