Diabetic Foot Ulcer
Conditions
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.
Interventions
OTHERfoot insole
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 The void measured 3 mm in depth.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* being between the ages of 50 and 65 years * males and females * with midfoot ulcer grades II or III * diabetic foot ulcer * the duration between 6 months and one year * diabetes mellitus incidence between seven and ten years * glycated hemoglobin between seven and nine (7 to 9%) * body mass index between 25 and 30 kg\|m2
Exclusion criteria
* Reynaud's disease * peripheral arterial disease * foot deformities * foot burns.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed