Plantar Pressure Distribution in Diabetic Foot Ulcer (PPDDFU)

• ClinicalTrials.gov Identifier: NCT05888259
• Recruitment Status: Enrolling by invitation
• First Posted: June 5, 2023
• Last Update Posted: June 5, 2023
• Sponsor: Cairo University
• Information provided by (Responsible Party): Hany Mohamed Ibrahim Elgohary, Cairo University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Diabetic Foot Ulcer	Other: foot insole	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Changes in Plantar Pressure Distribution After 12 Weeks of Foot Insole Utility in Diabetic Foot Ulcer Patients: a Prospective, Randomized, Double-blinded, Controlled Clinical Trial
• Actual Study Start Date: September 17, 2021
• Estimated Primary Completion Date: July 1, 2023
• Estimated Study Completion Date: July 20, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Other: 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.
Active Comparator: medication and wound care (control group); participants will receive only medical treatments and wound care for the diabetic foot ulcer	Other: 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.

Outcome Measures

Primary Outcome Measures :

1. peak pressures [ Time Frame: 12 weeks ]
   peak pressure for hindfoot, midfoot, hallux, medial and lateral forefoot
2. pressure-time integrals [ Time Frame: 12 weeks ]
   pressure time integral for hindfoot, midfoot, hallux, medial, and lateral forefoot

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Egypt

faculty of physical therapy, Cairo University

Giza, Egypt, 11432

Sponsors and Collaborators

Cairo University

Investigators

• Principal Investigator: Ebtsam H Allam, PHD; Cairo University
• Principal Investigator: Hany M Elgohary, PHD; Cairo University

More Information

Publications:

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.

• Responsible Party: Hany Mohamed Ibrahim Elgohary, associate professor, Cairo University
• ClinicalTrials.gov Identifier: NCT05888259
• Other Study ID Numbers: F.P.T2207014
• First Posted: June 5, 2023
• Last Update Posted: June 5, 2023
• Last Verified: June 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetic Foot; Foot Ulcer; Ulcer; Pathologic Processes; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases