Plantar Pressure Distribution in Diabetic Foot Ulcer

Not Applicable

• Conditions: Diabetic Foot Ulcer

• 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.

Study Timeline

• Study Start: 2021-09-17
• Study First Submitted: 2023-02-08
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-01
• Last Update Submitted: 2023-06-01
• Study First Posted: 2023-06-05
• Last Update Posted: 2023-06-05
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-20

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

• Reynaud's disease
• peripheral arterial disease
• foot deformities
• foot burns.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

Trial Locations

Locations (1)

faculty of physical therapy, Cairo University; 🇪🇬 Giza, Egypt