Status:
TERMINATED
Celliant Socks to Increase Tissue Oxygenation and Complete Wound Closure in Diabetic Foot Wounds
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Hologenix, LLC
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
This study is a prospective, multicenter, double-blind, 1:1 randomized clinical trial. The purpose of this study is to demonstrate that the use of Celliant Socks increases tissue oxygenation (via oxyg...
Detailed Description
Screening and Enrollment Patients who present to the investigator's institution (through clinic admission, direct transfer from another facility, or through the emergency room) may be recruited to pa...
Eligibility Criteria
Inclusion
- Diagnosis of diabetes mellitus
- Subject is willing and able to wear a sports-style tube sock at least 22 hours a day.
- Ankle Brachial Index (ABI) ≥0.5 (bedside ABI is acceptable for screening purposes as the formal imaging ABI may not be resulted prior to surgery) or toe pressure of ≥30mmHg
- One or more diabetic foot ulcers (only one will be treated) that are located in the ankle area or below that has persisted a minimum of 30 days prior to the Screening visit
- Diabetic Foot Ulcers ≥1cm2 and ≤16cm2
- Ulcer grade I or II, Stage A, I or II Stage B, according to University of Texas Wound Classification System
- 22 years of age or older
Exclusion
- Has clinically significant renal disease to require hemo or peritoneal dialysis
- Subject has untreated osteomyelitis
- Ulcers within 5cm of target ulcer or connected by fistulas
- Ulcer has decreased by 30% or more at the end of the run-in period
- Subject has untreated cellulitis
- Subject has untreated charcot
- Major immunodeficiency including HIV
- Is pregnant or plans to become pregnant
- Is nursing or actively lactating
- Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.
- Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's ability to provide informed consent, participate in the study protocol or record study materials
Key Trial Info
Start Date :
July 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2023
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04709419
Start Date
July 28 2022
End Date
April 4 2023
Last Update
January 15 2025
Active Locations (1)
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1
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390