Clinical trial NCT05888259: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot Ulcer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: peak pressures
timeFrame: 12 weeks
measure: pressure-time integrals
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: faculty of physical therapy, Cairo University
Study officials:
affiliation: Cairo University
name: Ebtsam H Allam, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Hany M Elgohary, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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.