Continuous Diffusion of Oxygen (CDO) Treatment for Healing of Diabetic Foot Ulcers
Condition: Foot Ulcer, Diabetic
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional

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.
    

Detailed description: 
      Patients seen at the University of Texas (UT) Southwestern Wound Clinic with a diabetic foot
      wound will be identified, consented, and screened for the study. Upon signing consent,
      patients will be assigned a unique screening number. The screening number given to the first
      patient will be 01 and increasing sequentially with each subject screened. Screened subjects
      will be entered onto a screening log. Once a number is assigned it cannot be re-assigned to
      another subject.

      At Day 0, a vascular evaluation including ABI, Sensilase, Transcutaneous oxygen measurements,
      and hyperspectral imaging will be performed. Monofilament Sensory Test and Vibration
      Perception Threshold(VPT) test will also be performed at day 0.Patients will undergo standard
      of care wound debridement. Tissue samples will be taken routinely as standard of care. A
      wound assessment will be performed, including the debridement as standard of care, wound
      measurements, and digital photos. Gene expression and bacterial analysis will be performed on
      tissue samples. After tests are performed, patient will receive topical oxygen therapy using
      the Transcutaneous O2 device with moist wound dressings. Moist wound dressings are used as
      standard of care. Patient will receive instructions to continue treatment at home.

      Patient will return for an appointment at days 7, 14, and 21, where vascular assessment
      (Sensilase, Transcutaneous oxygen measurements, Hyperspectral imaging) ,wound assessment
      (wound measurements, digital photos and acetate tracings) and tissue sampling will be
      performed following standard of care debridement, Patient will cease topical oxygen treatment
      at day 21, and study will be concluded.
    

Intervention name(s): Transcutaneous O2 device
Intervention type(s): Device
Intervention description(s): A portable device that delivers continuous diffusion of oxygen.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment