What is the mechanism of action of this treatment?

Common treatments for foot ulcers, such as those being studied with Celliant Socks, focus on increasing tissue oxygenation and promoting wound healing. These treatments work by enhancing blood flow and oxygen delivery to the affected area, which is crucial for cellular repair and regeneration. Improved oxygenation helps reduce infection risk, accelerates tissue repair, and supports the formation of new blood vessels. For foot ulcer patients, these mechanisms are vital as they directly address the underlying issues of poor circulation and impaired healing, leading to faster recovery and reduced complications.

What side effects are associated with this type of intervention?

Common treatments for foot ulcers that aim to increase tissue oxygenation and promote wound healing include hyperbaric oxygen therapy, topical oxygen therapy, and advanced wound dressings. Hyperbaric oxygen therapy can cause side effects such as ear pain, sinus pain, and in rare cases, oxygen toxicity. Topical oxygen therapy is generally well-tolerated but may cause mild skin irritation. Advanced wound dressings, like those containing silver or other antimicrobial agents, can sometimes lead to allergic reactions or local skin irritation.

What prior FDA approvals exist?

FDA-approved treatments for diabetic foot ulcers that focus on increasing tissue oxygenation and promoting wound healing include hyperbaric oxygen therapy (HBOT) and topical oxygen therapy. HBOT involves breathing pure oxygen in a pressurized room, which increases oxygen concentration in the blood and promotes healing. Topical oxygen therapy delivers oxygen directly to the wound site, enhancing tissue repair. Additionally, advanced wound care products like growth factors (e.g., becaplermin gel) and skin substitutes (e.g., Apligraf, Dermagraft) have been approved to aid in the healing of chronic foot ulcers.

What other types of research exist?

Promising alternatives to Celliant Socks for foot ulcer patients include: 1) Advanced wound dressings such as those containing growth factors or antimicrobial agents, 2) Topical oxygen therapy devices that deliver oxygen directly to the wound site, 3) Negative pressure wound therapy (NPWT) systems, and 4) Emerging pharmacological treatments like stem cell therapy or novel topical agents that enhance wound healing. These alternatives have shown potential in clinical studies for improving tissue oxygenation and promoting wound healing.

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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

Summary

This trial is testing whether special socks called Celliant Socks can help heal foot ulcers in people with diabetes. The socks are designed to improve blood flow and oxygen levels in the skin, which may speed up the healing process.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Tissue Oxygenation

Secondary study objectives

Number of Participants with Complete Wound Closure

Other study objectives

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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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for foot ulcers, such as those being studied with Celliant Socks, focus on increasing tissue oxygenation and promoting wound healing. These treatments work by enhancing blood flow and oxygen delivery to the affected area, which is crucial for cellular repair and regeneration. Improved oxygenation helps reduce infection risk, accelerates tissue repair, and supports the formation of new blood vessels. For foot ulcer patients, these mechanisms are vital as they directly address the underlying issues of poor circulation and impaired healing, leading to faster recovery and reduced complications.

Dressings and topical agents for arterial leg ulcers.