Diabetic Foot Clinical Trial
Official title:
Monitoring and Managing Newly Healed Chronic Leg and Foot Ulcer Skin Temperature: A Cooling Intervention (MUSTCOOL) to Prevent Ulcer Recurrence
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06154915 -
Immune Cells in Diabetic Chronic Foot Ulcers
|
||
Completed |
NCT04624516 -
Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence
|
N/A | |
Not yet recruiting |
NCT06278935 -
Lifestyle Tailored Offloading for Diabetic Foot Ulcers
|
N/A | |
Completed |
NCT02373592 -
Implementation of Foot Thermometry and SMS and Voice Messaging to Prevent Diabetic Foot Ulcer
|
N/A | |
Active, not recruiting |
NCT01903044 -
Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating
|
Phase 1/Phase 2 | |
Completed |
NCT02092870 -
Adipose Derived Regenerative Cellular Therapy of Chronic Wounds
|
Phase 2 | |
Completed |
NCT01212120 -
The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections
|
N/A | |
Completed |
NCT00402727 -
Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection
|
Phase 3 | |
Recruiting |
NCT04085705 -
The Prevalence of Contact Allergies for Wound Dressings In Patients With Diabetic Foot Ulcers (PAID Study)
|
||
Completed |
NCT04054804 -
Digital Foot Check by Using the D-Foot, a New Software
|
||
Not yet recruiting |
NCT04537676 -
Patient Empowerment Study
|
||
Completed |
NCT04480801 -
The Effect of Thermal Evaluation in Prevention of Diabetic Foot Ulcer
|
N/A | |
Recruiting |
NCT04564443 -
A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot
|
N/A | |
Recruiting |
NCT05974592 -
The Effect of Nurse-Led Diabetic Foot Self-Management Training Program
|
N/A | |
Not yet recruiting |
NCT04630795 -
ViscoTurf - Preventing Secondary Diabetic Foot Ulceration.
|
||
Not yet recruiting |
NCT05431660 -
Diabetic Foot School and Biomechanics
|
N/A | |
Completed |
NCT05101473 -
Exercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study
|
N/A | |
Completed |
NCT05123157 -
Pattern and Type of Amputation and Mortality Rate Associated With Diabetic Foot in Jeddah, Saudi Arabia: A Retrospective Cohort Study
|
||
Enrolling by invitation |
NCT05043636 -
Diabetic Neuropathy Screening Study 1.1 + Substudy 1.2-1.3-1.4
|
||
Completed |
NCT03254095 -
Predictors of Skin Temperature, Plantar Pressure and Ulceration in Diabetic Foot Patients.
|