Back to resultsEfficacy of Human Placental Graft in Diabetic Foot Ulcers
Primary Purpose
Diabetic Foot
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Revita Allograft
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot
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
Sites / Locations
- Gulf Coast PodiatryRecruiting
- Louisiana Foot and Ankle SpecialistsRecruiting
- Springfield Hospital - Center for Wound HealingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Treatment
Control
Arm Description
Will receive Revita allograft for wound treatment
Will receive current standard of care for wound treatment
Outcomes
Primary Outcome Measures
Complete Wound Closure
100% epithelization
Secondary Outcome Measures
Percent(%) Healed
Percentage of wound healed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03708029
Brief Title
Efficacy of Human Placental Graft in Diabetic Foot Ulcers
Official Title
A Clinical Investigation Into the Efficacy of Full-thickness Human Placental Graft (Revita) in Diabetic Foot Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 13, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
StimLabs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Treatment
Arm Type
Experimental
Arm Description
Will receive Revita allograft for wound treatment
Arm Title
Control
Arm Type
No Intervention
Arm Description
Will receive current standard of care for wound treatment
Intervention Type
Other
Intervention Name(s)
Revita Allograft
Intervention Description
Human placental allograft
Primary Outcome Measure Information:
Title
Complete Wound Closure
Description
100% epithelization
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Percent(%) Healed
Description
Percentage of wound healed
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Research Manager
Phone
4706160997
Email
bwilliams@stimlabs.com
First Name & Middle Initial & Last Name or Official Title & Degree
VP Clinical Development
Email
chas@stimlabs.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Research Manager
Organizational Affiliation
StimLabs
Official's Role
Study Director
Facility Information:
Facility Name
Gulf Coast Podiatry
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Kiefer, DPM
First Name & Middle Initial & Last Name & Degree
Joseph Kiefer, DPM
Facility Name
Louisiana Foot and Ankle Specialists
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Hall, DPM
First Name & Middle Initial & Last Name & Degree
Daniel Hall, DPM
First Name & Middle Initial & Last Name & Degree
Mallory Przybylski, DPM
Facility Name
Springfield Hospital - Center for Wound Healing
City
Springfield
State/Province
Pennsylvania
ZIP/Postal Code
19064
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris Barrett, DPM
First Name & Middle Initial & Last Name & Degree
Chris Barrett, DPM
First Name & Middle Initial & Last Name & Degree
Sneha Patel, DPM
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Human Placental Graft in Diabetic Foot Ulcers
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