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Plantar Pressure Distribution in Diabetic Foot Ulcer (PPDDFU)

Primary Purpose

Diabetic Foot Ulcer

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
foot insole
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • faculty of physical therapy, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

foot insole, medication and wound care (study group)

medication and wound care (control group)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

peak pressures
peak pressure for hindfoot, midfoot, hallux, medial and lateral forefoot
pressure-time integrals
pressure time integral for hindfoot, midfoot, hallux, medial, and lateral forefoot

Secondary Outcome Measures

Full Information

First Posted
February 8, 2023
Last Updated
June 1, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05888259
Brief Title
Plantar Pressure Distribution in Diabetic Foot Ulcer
Acronym
PPDDFU
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 17, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
foot insole, medication and wound care (study group)
Arm Type
Experimental
Arm Description
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.
Arm Title
medication and wound care (control group)
Arm Type
Active Comparator
Arm Description
participants will receive only medical treatments and wound care for the diabetic foot ulcer
Intervention Type
Other
Intervention Name(s)
foot insole
Intervention Description
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.
Primary Outcome Measure Information:
Title
peak pressures
Description
peak pressure for hindfoot, midfoot, hallux, medial and lateral forefoot
Time Frame
12 weeks
Title
pressure-time integrals
Description
pressure time integral for hindfoot, midfoot, hallux, medial, and lateral forefoot
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebtsam H Allam, PHD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hany M Elgohary, PHD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
faculty of physical therapy, Cairo University
City
Giza
ZIP/Postal Code
11432
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31435359
Citation
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.
Results Reference
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Plantar Pressure Distribution in Diabetic Foot Ulcer

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