Plantar Pressure Distribution in Diabetic Foot Ulcer

NCT05888259 | Unknown DMC

• 1 other identifier: F.P.T2207014
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

foot insole, medication and wound care (study group)

EXPERIMENTAL

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

medication and wound care (control group)

ACTIVE COMPARATOR

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

Other: foot insole

Interventions

foot insole 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.

foot insole, medication and wound care (study group); medication and wound care (control group)

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of physical therapy, Cairo University

Giza, 11432, Egypt

Location

Related Publications (1)

• 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.

  PMID: 31435359 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Ebtsam H Allam, PHD

  Cairo University

  PRINCIPAL INVESTIGATOR

• Hany M Elgohary, PHD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: June 5, 2023
• Study Start: September 17, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 20, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)