Slowly Reloading To Prevent (Stop) Ulcer Recurrence Following Plantar Diabetic Foot Ulcers
Study on Daily Activity and Ulcer Recurrence in Diabetic Foot Ulcers
Mithun Sinha
Primary Investigator
Brief description of study
There is an immediate need for data informing the role of daily loading in DFU recurrence, and also an immediate need for a clinical approach to mitigate risk in a way that is feasible for both facilities and patients. This research will provide the requisite information to develop targets for daily loading to facilitate further healing and reduce risk of re-ulceration while assessing the feasibility of using a telehealth approach to provide patient touchpoints for risk reduction. With this information, future studies can evaluate the prescription of daily limb loading to improve long-term outcomes for patients with DFU.
Detailed description of study
This study will utilize activPAL™, a miniature electronic logger designed to quantify free-living daily activities.
When you move, it moves, generating totals for the time spent lying, sitting, standing, and stepping every second of the day.
This device will aid in understanding offloading practices among patients with recently healed diabetic foot ulcers.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Diabetes, Plantar Diabetic Foot Ulcer
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria
• Age greater than 18
• Diagnosis of diabetes with or without peripheral neuropathy
• Selection of one weight-bearing wound that has closed
• Able to safely walk with or without assistive devices
• Compliant with prescribed offloading supporting (e.g., casting, diabetic footwear, and/or other inserts)
• Recently closed Diabetic Foot Ulcer (within the last month) as defined by the FDA as “100% wound surface re-epithelialization without discernible exudate, drainage, and dressing requirements confirmed at two consecutive study/ clinical visits two weeks apart.”1
Exclusion Criteria
• Participants without a diagnosis of diabetes
• Wound is deemed active and open
• Wound has underlying infection, osteomyelitis, or gangrene
• Participants who are non-ambulatory
• Participants who have allergies to adhesives
• Participants unable or unwilling to participate with telehealth visits
This study investigates diabetic foot ulcers, which are wounds that occur on the feet of people with diabetes. The purpose of this study is to understand how daily activities affect the recurrence of these ulcers. The study will use a small device called activPAL™ to track daily movements such as lying down, sitting, standing, and stepping. This helps researchers learn about how patients manage their activities after their foot ulcers have healed.
Participants will wear the activPAL™ device, which records their movements throughout the day. This will help researchers understand the role of daily loading, which means the stress placed on feet during activities, in preventing ulcers from coming back. The study also explores using telehealth, which involves talking with healthcare providers through technology, to help reduce the risk of ulcers returning.
- Who can participate: Adults over 18 with diabetes who have recently healed a foot ulcer can participate. Participants must walk safely and follow prescribed foot care routines.
- Study details: Participants will wear a small device to track daily activities, helping researchers understand foot care practices. The study may involve telehealth visits with healthcare providers.
