Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence
Condition: Venous Hypertension Ulcers; Venous Stasis Ulcer; Venous Ulcer; Venous Insufficiency; Leg Ulcer; Foot Ulcer; Varicose Ulcer; Diabetic Foot
MeSH terms: Diabetic Foot; Venous Insufficiency; Varicose Ulcer; Foot Ulcer; Leg Ulcer; Ulcer; Recurrence
Intervention: Cooling gel pack; Cooling cotton pack
Intervention description: Individuals will self monitor skin temperature of skin over a recently health venous leg or diabetic foot ulcer with a dermal thermometer. A cooling gel pack will be applied to skin of recently healed venous leg or diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increases and stays elevated 2°F above the usual temperature of that site, the individual will cool the skin 5 consecutive days and will continue to monitor skin temperature.; Individuals will self monitor skin temperature of skin over a recently health venous leg or diabetic foot ulcer with a dermal thermometer. A cotton filled pack will be applied to skin of recently healed venous leg or diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increases and stays elevated 2°F above the usual temperature of that site, the individual will cool the skin 5 consecutive days and will continue to monitor skin temperature.
Intervention MeSH terms: Methyl salicylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 140.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: post healed venous leg ulcer; posted healed diabetic foot ulcer

Summary:

      The goal of this study is to test MUSTCOOL, a home-based self-monitoring and self-management
      ulcer prevention intervention for patients with newly healed chronic venous leg and diabetic
      foot ulcers. Almost 90% of ulcers recur within 3 months of healing. During the six-month
      randomized clinic trial, skin temperature will be monitored daily, a maintenance dose of
      cooling gel pack or placebo will be applied three times weekly to the affected skin, and a
      bolus dose of cooling will be applied for 5 consecutive days if skin temperature becomes
      elevated. Outcomes on the incidence of leg ulcer recurrence, pain, physical activity and
      quality of life will be measured.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly healed leg or diabetic foot ulcer within past 7 - 14 days

          -  Ankle brachial index 0.8- 1.3mmHg (rule out absence of arterial disease)

          -  Willing to wear compression stockings and appropriate footwear

          -  Working freezer

        Exclusion Criteria:

          -  Open leg or foot ulcers

          -  Cognitive impairment: unable to recall 2 or more words or draw clock Mini-Cog™ for
             cognitive impairment

          -  Chronic inflammatory or vascular conditions where blood flow of skin may be impaired
             such as Lupus erythematosus, Raynaud's, scleroderma, end stage renal disease, chronic
             regional pain syndrome, multiple sclerosis, hypersensitivity to cold, on chemotherapy

          -  Unable to preform required protocol activities without assistance (return
             demonstration to study staff)