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Celliant Socks to Increase Tissue Oxygenation and Complete Wound Closure in Diabetic Foot Wounds

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ClinicalTrials.gov Identifier: NCT04709419
Recruitment Status : Not yet recruiting
First Posted : January 14, 2021
Last Update Posted : January 19, 2021
Sponsor:
Collaborator:
Hologenix, LLC
Information provided by (Responsible Party):
Larry Lavery, University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Device: Celliant Diabetic Medical Socks Device: Control (placebo) Medical Socks Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Treatment
Official Title: Study to Evaluate Celliant Diabetic Medical Socks to Increase Tissue Oxygenation and Incidence of Complete Wound Closure in Diabetic Foot Wounds
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Celliant Sock
Celliant® Diabetic Medical Socks ("Celliant Socks") are intended to provide infrared radiation (IR) to increase tissue oxygen thereby increasing blood flow and circulation in the affected area leading to an effect on wound closure outcomes and possible pain reduction. Celliant® fibers are comprised of a proprietary blend of infrared (IR) emitting ceramic materials mixed with polyethylene terephthalate (PET). The proprietary blend consists of the following components: alumina oxide; silicon dioxide; and titanium dioxide. The Celliant fibers are woven or knitted into yarn and used to manufacture the Celliant Sock. The Celliant Sock content will be 82% Celliant polyester, 13% Nylon and 5% Spandex. Celliant fibers absorb energy (heat) generated by the wearer's body by radiation, convection and conduction, and also from the environment, and re emit the energy as infrared radiation back into the wearer's body.
Device: Celliant Diabetic Medical Socks
Celliant® Diabetic Medical Socks ("Celliant Socks") are intended to provide infrared radiation (IR) to increase tissue oxygen thereby increasing blood flow and circulation in the affected area leading to an effect on wound closure outcomes and possible pain reduction.

Sham Comparator: Control Sock
The Control Sock will be visually identical to the Active Celliant® Sock. The sock will be made of identical materials without the Celliant® components. The Control sock will be 82% standard polyester, 13% Nylon, and 5% Spandex.
Device: Control (placebo) Medical Socks
The Control Sock will be visually identical to the Active Celliant® Sock. The sock will be made of identical materials without the Celliant® components. The Control sock will be 82% standard polyester, 13% Nylon, and 5% Spandex.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of Participants with Complete Wound Closure [ Time Frame: 12 weeks ]
    To compare the incidence of complete wound closure as defined as skin reepithelialization without drainage.


Other Outcome Measures:
  1. Number of Patients with Maintained Wound Closure [ Time Frame: 3 months ]
    The number of patients with maintained wound closure.



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04709419


Contacts
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Contact: Tara Kristof 2146488602 tara.kristof@utsouthwestern.edu
Contact: Debby Noble 214-648-8686 debby.noble@utsouthwestern.edu

Locations
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United States, Texas
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Hologenix, LLC
Investigators
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Principal Investigator: Lawrence A Lavery, DPM MPH UT Southwestern Medical Center
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Responsible Party: Larry Lavery, Professor and Director of Research, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04709419    
Other Study ID Numbers: STU-2020-1386
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: 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