MedTrace Logo

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

NCT02626156 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2021-06-30

Study results available
· View outcomes & findings →

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.

Conditions

  • Venous Hypertension Ulcers
  • Venous Stasis Ulcer
  • Venous Ulcer
  • Venous Insufficiency
  • Leg Ulcer
  • Foot Ulcer
  • Varicose Ulcer
  • Diabetic 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.

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Moby Madisetti, MS · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-01
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02626156 on ClinicalTrials.gov