Plantar Pressure Distribution in Diabetic Foot Ulcer (PPDDFU)

Cairo University (CU)

Status: Invitation-only

Conditions: Diabetic Foot Ulcer

Treatments: Other: foot insole

Study type: Interventional

Funder types: Other

Identifiers

NCT05888259

F.P.T2207014

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

foot insole, medication and wound care (study group)

Experimental group

Description:

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.

Treatment:

Other: foot insole

medication and wound care (control group)

Active Comparator group

Description:

participants will receive only medical treatments and wound care for the diabetic foot ulcer

Treatment:

Other: foot insole