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Device
Celliant Socks for Foot Ulcers
N/A
Waitlist Available
Led By Lawrence A Lavery, DPM MPH
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial will compare Celliant socks to regular socks in terms of their ability to increase tissue oxygenation and promote wound healing in people with diabetes.
Who is the study for?
This trial is for adults over 22 with diabetes and foot ulcers that have lasted at least 30 days. Participants must be able to wear special tube socks almost all day and have an ulcer size between ≥1cm² and ≤16cm². They should not require dialysis, be pregnant or nursing, or have untreated bone infections, significant psychological disorders, substance abuse issues, or immune deficiencies.Check my eligibility
What is being tested?
The study tests if Celliant Diabetic Medical Socks can increase oxygen levels in tissues and help close wounds in diabetic foot ulcers better than placebo socks. It's a double-blind trial where participants are randomly assigned to either the test group or control group equally.See study design
What are the potential side effects?
Since this trial involves wearing therapeutic socks rather than taking medication, side effects may include skin irritation or discomfort from sock use. However, specific side effects related to the product will be monitored throughout the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Tissue Oxygenation
Secondary outcome measures
Number of Participants with Complete Wound Closure
Other outcome measures
Number of Patients with Maintained Wound Closure
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Celliant SockExperimental Treatment1 Intervention
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.
Group II: Control SockPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,795 Total Patients Enrolled
17 Trials studying Foot Ulcer
4,694 Patients Enrolled for Foot Ulcer
Hologenix, LLCIndustry Sponsor
2 Previous Clinical Trials
60 Total Patients Enrolled
Lawrence A Lavery, DPM MPHPrincipal InvestigatorUT Southwestern Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have serious kidney disease that requires dialysis.You have a bone infection that has not been treated yet.You have been diagnosed with diabetes.Your ankle brachial index (ABI) is at least 0.5, or your toe pressure is at least 30mmHg.You have a foot sore from diabetes that has been there for at least 30 days and is located on or below the ankle.You have a mild or moderate ulcer according to the University of Texas Wound Classification System.The ulcer has shrunk by 30% or more at the end of the initial period.You have untreated skin infection called cellulitis.You have a significant mental disorder that could make it hard for you to understand the study, take part in it, or keep track of your progress. This includes untreated schizophrenia, bipolar disorder, or being hospitalized for a mental health issue within the last 2 years.You have a foot condition called Charcot that has not been treated.You have a serious immune system problem, including HIV.You have ulcers that are close to the target ulcer or connected by fistulas.You must wear a special type of sock for at least 22 hours every day and be willing to do so.You have a diabetic foot ulcer that is between 1 square centimeter and 16 square centimeters in size.
Research Study Groups:
This trial has the following groups:- Group 1: Celliant Sock
- Group 2: Control Sock
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are participating in this research endeavor?
"Confirmed. According to clinicaltrials.gov, this research endeavour was first unveiled on October 27th 2022 and recently amended on December 1st 2022; thus it is actively searching for 254 individuals across a single site."
Answered by AI
Is it possible to register for this clinical research at present?
"Evidenced by clinicaltrials.gov, this medical trial is actively seeking participants and was first posted on October 27th 2022 with the most recent edit occuring December 1st 2022."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
UT Southwestern Medical Center at Dallas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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