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

NCT ID: NCT02626156

Last Updated: 2021-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-01
• Study Completion Date: 2020-03-31

Brief 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.

Detailed Description

The goal of this randomized control trial is to test a patient directed self-monitoring and self-management intervention aimed at preventing the recurrence of chronic venous leg and diabetic foot ulcers using skin temperature and cryotherapy (cooling). This MUSTCOOL study is a novel ulcer prevention strategy for patients at highest risk for developing chronic ulcers; those with a previous history. The aims are to compare a cooling treatment to a placebo to determine the outcomes on ulcer recurrence, pain, physical activity and quality of life.

Individuals with newly healed chronic ulcers will be invited to participate in MUSTCOOL's two component intervention:

1. self monitoring skin temperature over targeted "hot spots" daily with an infrared thermometer; and

2. maintenance cooling with a cooling pack (or placebo pack) placed over the "hot spot" three times each week for 30 minutes. If the temperature of the "hot spot" becomes elevated 2°F above baseline (average of 30 days of daily temperature readings) for 2 days in a row, a bolus regimen of 5 consecutive daily, 30 minute applications of the cooling or placebo pack will be implemented. The safety and side effects will be monitored, however, there have been no reported adverse events reported in our previous cryotherapy studies.

This study was designed as a chronic ulcer prevention intervention that targets the remodeling phase, the final repair process of healing after chronic ulcer closure. The skin environment is particularly vulnerable to ulcer recurrence due to a persistent aberrant inflammatory state. The previous research conducted by the study team has demonstrated that cooling this skin reduces the abnormal metabolic activity, protecting it against ulcer recurrence. Recent advancements in infrared technology allow us to take images of the affect skin to identify the area that has the highest temperature or vulnerable "hot spot". These "hot spots" will be self monitored by patients with newly healed ulcers in the home with an infrared thermometer that date and time stamps each reading. The study's outcomes on physical activity will be evaluated with an accelerometer. It is hypothesized that by improving the skin environment and reducing pain, patients will more likely be physically active and have better quality of life, all measurable goals for this study.

This prevention strategy will be evaluated over six months in 180 patients, 90 of whom will be randomized to receive the cooling pack and 90 the placebo. The goal is to test this non-pharmacological, non-invasive clinical intervention as a tailored self-management strategy to prevent chronic ulcer recurrence. It will also determine alleviation of symptoms such as pain, and the debilitating effects on physical activity and quality of life.

Conditions

Venous Hypertension Ulcers; Venous Stasis Ulcer; Venous Ulcer; Venous Insufficiency; Leg Ulcer; Foot Ulcer; Varicose Ulcer; Diabetic Foot

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cooling gel pack

A cooling pack will be applied to affected leg or foot skin where an ulcer has recently healed for 30 minutes three times a week (preventive maintenance). Patients will self monitor skin temperature of affected skin daily to detect elevation and will cool the affected skin daily for 5 consecutive days (bolus) if the skin temperature becomes elevated 2°F above the baseline.

Group Type: EXPERIMENTAL

Cooling gel pack

Intervention Type: DEVICE

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.

Cooling cotton pack

A cooling cotton pack will be applied to affected leg or foot skin where an ulcer has recently healed for 30 minutes three times a week (preventive maintenance). Patients will self monitor skin temperature of affected skin daily to detect elevation and will cool the affected skin daily for 5 consecutive days (bolus) if the skin temperature becomes elevated 2°F above the baseline.

Group Type: ACTIVE_COMPARATOR

Cooling cotton pack

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moby Madisetti, MS

Role: STUDY_DIRECTOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

Countries

United States

References

Kelechi TJ, Mueller M, Madisetti M, Prentice M. Efficacy of a Self-managed Cooling Intervention for Pain and Physical Activity in Individuals With Recently Healed Chronic Venous Leg and Diabetic Foot Ulcers: A Randomized Controlled Trial. J Wound Ostomy Continence Nurs. 2022 Jul-Aug 01;49(4):365-372. doi: 10.1097/WON.0000000000000880. Epub 2022 May 4.

Reference Type: DERIVED

PMID: 35507774 (View on PubMed)

Kelechi TJ, Madisetti M, Prentice M, Mueller M. Cooling Intervention (MUSTCOOL) for Prevention of Lower Extremity Ulcer Recurrence: A Randomized Controlled Trial. J Wound Ostomy Continence Nurs. 2021 May-Jun 01;48(3):203-210. doi: 10.1097/WON.0000000000000753.

Reference Type: DERIVED

PMID: 33735146 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00043450

Identifier Type: -

Identifier Source: org_study_id