Study to Evaluate Celliant Diabetic Medical Socks to Increase Tissue Oxygenation and Incidence of Complete Wound Closure in Diabetic Foot Wounds
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 4
- Locations
- 2
- Primary Endpoint
- Change in Tissue Oxygenation
Study Overview
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 oxygen saturation, StO2) and incidence of wound closure in subjects with diabetic foot ulcers. This study will use hyperspectral imaging and wound assessment to measure these outcomes. The study will enroll 254 evaluable subjects total, 127 per arm to meet the Primary Endpoint. Enrollment may continue up to twenty-five hundred (2500) evaluable subjects total to meet the Key Secondary Endpoint of complete wound closure.
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 participate in the study. No direct marketing for subject recruitment will be done.
Patients approached for study participation will be at least 22 years of age at the time of consent, will undergo wound assessment, and meet all eligibility requirements. Those meeting eligibility criteria for the study will have the study explained to them by the Investigator. An Informed Consent Form will be provided to sign according to Section 11 prior to undergoing any study procedures. Patients will be encouraged to ask questions of the investigators. It will be made clear to the patient that not participating in the study will in no way influence the treatment plan or the relationship with the physician.
Wound Selection
Only one wound per subject will be included in the study. Subjects with multiple wounds will have each wound measured for volume. The wound with the largest volume meeting all eligibility requirements will be chosen for inclusion in the study. The etiology of the chosen wound, and if it is a new or recurring, will be documented.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
Active and Control samples will be prepared in sealed and labeled as A or B Randomization envelopes (A&B) will be provided to the research staff and used to obtain randomization assignment. After run-in evaluation subjects who continue to meet all inclusion and no exclusion criteria will be randomized in a 1:1 ratio to be treated with either Control or Celliant therapies, stratified by wound size (greater than size of 4 cm2) and study center. Study staff will use the randomization number labels and sock assignment of socks A or B contained in the envelope. The number will become the subject ID. The research staff will note the randomization number and the treatment assignment letter (A or B) on the CRF. The key, indicating therapy assignments (Active or Control), will only be available to staff not directly involved in the study until after the subject has completed study activities.
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Change in Tissue Oxygenation
Time Frame: 12 weeks
To compare the percent change from baseline in tissue oxygenation in Celliant and Control treated groups as measured by hyperspectral imaging.
Secondary Outcomes
- Number of Participants With Complete Wound Closure(12 weeks)
Investigators
Larry Lavery
Professor and Director of Research
University of Texas Southwestern Medical Center