Plantar Pressure Distribution in Diabetic Foot Ulcer
- Conditions
- Diabetic Foot Ulcer
- Interventions
- Other: foot insole
- Registration Number
- NCT05888259
- Lead Sponsor
- Cairo University
- Brief Summary
The goal of this clinical trial is to find out the changes in peak pressure and pressure-time integral after twelve weeks from the initial utility of foot insoles and eight weeks later as a follow-up in diabetic foot ulcers. Participants will be randomly assigned to foot insole, medication, and wound care (study group) or medication and wound care (control group).
- Detailed Description
Insole design The foot insole is 5 mm thick under the flat part of the forefoot and the modification is done by changing the position of the metatarsal bar. This was another 5 mm above the flat part of the foot insole. The proximal/distal position of the metatarsal rod and the cavity distal to the rod (large cavity) were defined using the plantar pressure distribution. The position and shape of the distal end of the metatarsal bar were defined by a line in the area where the plantar pressure was 75% of the maximum plantar pressure. This line also defined the void's proximal border. The void's distal border was housed near the area of peak plantar pressures, where pressure was 10% of peak plantar pressure. The void measured 3 mm in depth. After completing the initial design of the metatarsal bars and void, two variations were created by relocating the metatarsal bar proximal and distal by 2-4% of the insole length depending on the position of the foot ulcer. Based on a previous pilot study, this proportion equates to a distance of 5-7 mm on a size 38 orthotic insole. The orthotic insoles were made of medium-density (Ethylene-vinyl acetate) EVA (50° Shore A) and were manufactured on a CNC machine.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 60
Not provided
- Reynaud's disease
- peripheral arterial disease
- foot deformities
- foot burns.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description foot insole, medication and wound care (study group) foot insole Pressure maps were recorded to calculate peak pressures and pressure-time integrals for (hindfoot, middle foot, hallux, medial forefoot, and lateral forefoot). The measurements were uploaded to a server of software that uses technology to create a 3D model of the foot insole from multiple images taken by the user. medication and wound care (control group) foot insole participants will receive only medical treatments and wound care for the diabetic foot ulcer
- Primary Outcome Measures
Name Time Method peak pressures 12 weeks peak pressure for hindfoot, midfoot, hallux, medial and lateral forefoot
pressure-time integrals 12 weeks pressure time integral for hindfoot, midfoot, hallux, medial, and lateral forefoot
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
faculty of physical therapy, Cairo University
🇪🇬Giza, Egypt