Plantar Pressure Distribution in Diabetic Foot Ulcer

NCT ID: NCT05888259

Last Updated: 2023-06-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-17
• Study Completion Date: 2023-07-20

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.

Conditions

Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

foot insole, medication and wound care (study group)

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.

Group Type: EXPERIMENTAL

foot insole

Intervention Type: OTHER

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.

medication and wound care (control group)

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

Group Type: ACTIVE_COMPARATOR

foot insole

Intervention Type: OTHER

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.

Interventions

foot 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.

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hany Mohamed Ibrahim Elgohary

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ebtsam H Allam, PHD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Hany M Elgohary, PHD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

faculty of physical therapy, Cairo University

Giza, , Egypt

Countries

Egypt

References

Elgohary HM, Al Jaouni SK, Selim SA. Effect of ultrasound-enhanced Nigella sativa seeds oil on wound healing: An animal model. J Taibah Univ Med Sci. 2018 Jun 27;13(5):438-443. doi: 10.1016/j.jtumed.2018.02.008. eCollection 2018 Oct.

Reference Type: BACKGROUND

PMID: 31435359 (View on PubMed)

Other Identifiers

F.P.T2207014

Identifier Type: -

Identifier Source: org_study_id