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

NCT04709419 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-01-15

Study results available
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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.

Conditions

  • Diabetic Foot Ulcer

Interventions

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.

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.

Sponsors & Collaborators

  • Hologenix, LLC

    collaborator INDUSTRY

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Lawrence A Lavery, DPM MPH · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-28
Primary Completion
2023-04-04
Completion
2023-04-04
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04709419 on ClinicalTrials.gov