Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence

PHASE2CompletedINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

June 1, 2015

Primary Completion Date

March 31, 2020

Study Completion Date

March 31, 2020

Conditions
Venous Hypertension UlcersVenous Stasis UlcerVenous UlcerVenous InsufficiencyLeg UlcerFoot UlcerVaricose UlcerDiabetic Foot
Interventions
DEVICE

Cooling gel pack

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.

DEVICE

Cooling cotton pack

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.

Trial Locations (2)

29303

Spartanburg Regional Medical Center, Spartanburg

29412

Medical University of South Carolina, Charleston

All Listed Sponsors
lead

Medical University of South Carolina

OTHER

NCT02626156 - Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence | Biotech Hunter | Biotech Hunter