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Efficacy of Human Placental Graft in Diabetic Foot Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03708029
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
StimLabs

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

Condition or disease Intervention/treatment Phase
Diabetic Foot Other: Revita Allograft Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Investigation Into the Efficacy of Full-thickness Human Placental Graft (Revita) in Diabetic Foot Ulcers
Actual Study Start Date : November 13, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Complete Wound Closure [ Time Frame: 12 weeks ]
    100% epithelization


Secondary Outcome Measures :
  1. Percent(%) Healed [ Time Frame: 12 weeks ]
    Percentage of wound healed



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03708029


Contacts
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Contact: Clinical Research Manager 4706160997 bwilliams@stimlabs.com
Contact: VP Clinical Development chas@stimlabs.com

Locations
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United States, Florida
Gulf Coast Podiatry Recruiting
Pensacola, Florida, United States, 32503
Contact: Joseph Kiefer, DPM         
Principal Investigator: Joseph Kiefer, DPM         
United States, Louisiana
Louisiana Foot and Ankle Specialists Recruiting
Lake Charles, Louisiana, United States, 70605
Contact: Daniel Hall, DPM         
Principal Investigator: Daniel Hall, DPM         
Sub-Investigator: Mallory Przybylski, DPM         
United States, Pennsylvania
Springfield Hospital - Center for Wound Healing Recruiting
Springfield, Pennsylvania, United States, 19064
Contact: Chris Barrett, DPM         
Principal Investigator: Chris Barrett, DPM         
Sub-Investigator: Sneha Patel, DPM         
Sponsors and Collaborators
StimLabs
Investigators
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Study Director: Clinical Research Manager StimLabs
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Responsible Party: StimLabs
ClinicalTrials.gov Identifier: NCT03708029    
Other Study ID Numbers: SLRV-POD-WC-001
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases