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

Tracking Information

• First Submitted Date: February 8, 2023
• First Posted Date: June 5, 2023
• Last Update Posted Date: June 5, 2023
• Actual Study Start Date: September 17, 2021
• Estimated Primary Completion Date: July 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 1, 2023)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Plantar Pressure Distribution in Diabetic Foot Ulcer
• 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Diabetic Foot Ulcer

Intervention

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.

Study Arms

• 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.

  Intervention: Other: foot insole
• Active Comparator: medication and wound care (control group)
  participants will receive only medical treatments and wound care for the diabetic foot ulcer
  Intervention: Other: foot insole

• 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.

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: June 1, 2023): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 20, 2023
• Estimated Primary Completion Date: July 1, 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT05888259
• Other Study ID Numbers: F.P.T2207014
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Hany Mohamed Ibrahim Elgohary, Cairo University
• Original Responsible Party: Same as current
• Current Study Sponsor: Cairo University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Cairo University
• Verification Date: June 2023