Plantar Pressure Distribution in Diabetic Foot Ulcer (PPDDFU)

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

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Other: foot insole

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 11432
    • Faculty of physical therapy, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
peak pressures	peak pressure for hindfoot, midfoot, hallux, medial and lateral forefoot	12 weeks
pressure-time integrals	pressure time integral for hindfoot, midfoot, hallux, medial, and lateral forefoot	12 weeks

Collaborators and Investigators

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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2021
• Primary Completion (Estimated): July 1, 2023
• Study Completion (Estimated): July 20, 2023

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: F.P.T2207014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No