Continuous Diffusion of Oxygen (CDO) Treatment for Healing of Diabetic Foot Ulcers

NCT02501538 | Completed Results FDA Device

• 1 other identifier: 012015-051
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study. Maximum 30 subjects with a diabetic foot ulcer (DFU) or surgical foot wound will be consented in order to have 20 eligible subjects who will be enrolled and completed the study. Study duration will be three weeks. Patients will be consented and undergo debridement as standard of care at day 0. Ankle-Brachial Index (ABI), Monofilament Sensory Test and Vibration Perception Threshold(VPT) test will be performed only at day 0. Tissue samples will be taken at this visit during standard of care wound debridement and these tissue samples of the wound would normally be removed as part of routine debridement. These tissue samples of the wound will be used for gene expression and bacterial analysis(research). The patient will then receive topical oxygen therapy using the Transcutaneous O2 device (research) with moist wound dressings for 21 days. Moist wound dressings are used as standard of care. Treatment will be initiated during Screening/Baseline visit(day 0) after routine wound debridement, and patient will receive instructions for home use of the device. The patient will be seen for routine wound debridement at days 7, 14, and 21 with a study window of 5 days., Digital photos of the wound, and vascular evaluations (Transcutaneous oxygen measurements and Hyperspectral imaging. will be performed at each study visit(research). Tissue samples will be taken during standard of care wound debridement at every study visit. Results of the data analysis from this project will be used to inform the design of a larger randomized clinical trial.

Conditions

Foot Ulcer, Diabetic

Outcome Measures

Primary Outcomes (2)

• Tissue Oxygenation as Measured by Hyperspectral Imaging

  Hyperspectral (HyperMed, Inc.) images were taken for evaluation of tissue oxygenation following debridement at Visit 1 (day 0), visit 2 (day 7), visit 3 (day 14), visit 4 (day 21). Two images were taken of the study foot - one of the plantar surface and one of the dorsal surface to evaluate the oxygenation of the entire foot. Measurements of oxygenated hemoglobin are generated by the camera for each image. Results are reported in aggregate as mean/standard error for all time points.

  21 days

• Tissue Perfusion as Measured by TCPO2

  Transcutaneous oxygen pressure (TCPO2) was measured at visit 1 (day 0), visit 2 (day 7), visit 3 (day 14), visit 4 (day 21) to assess perfusion of the tissue. This is measured at the medial and lateral foot to include both major blood vessels to the foot. Reported here as aggregate mean over all time points.

  21 days

Secondary Outcomes (3)

• Change in Levels of Growth Factors and Cytokines Involved in Wound Healing

  21 days

• Evaluate Changes in Bacterial Infection

  21 days

• Percent Wound Area Reduction

  21 days

Study Arms (1)

Transcutaneous O2 device

EXPERIMENTAL

Continuous diffusion of oxygen (CDO) (topical oxygen) therapy, which will be administered using a portable device.

Device: Transcutaneous O2 device

Interventions

Transcutaneous O2 device DEVICE

A portable device that delivers continuous diffusion of oxygen.

Transcutaneous O2 device

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects of all races and ethnicities, age 18-89
• Diagnosis of diabetes mellitus
• Has a diabetic foot ulcer

You may not qualify if:

• End-stage renal disease (ESRD)
• Has untreated foot ulcer at time of study
• HIV, hepatitis, autoimmune disease, Systemic lupus erythematous (SLE), Raynaud's disease
• Ankle-Brachial Index (ABI) \< 0.4
• Unable or unwilling to provide informed consent

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: Lawrence Lavery, DPM, MPH
• Organization: UT Southwestern Medical Center at Dallas

Larry.Lavery@UTSouthwestern.edu

214-645-0544

Study Officials

• Lawrence A Lavery, DPM

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lawrence A Lavery, DPM Study Principal Investigator

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: July 17, 2015
• Study Start: June 1, 2015
• Primary Completion: January 10, 2019
• Study Completion: January 10, 2020
• Last Updated: July 24, 2023
• Results First Posted: August 13, 2020

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)