Status:
COMPLETED
Functional Ankle Taping Correction on Plantar Foot Ulcer Healing in Diabetic Patients
Lead Sponsor:
MTI University
Conditions:
Foot Ulcer
Eligibility:
All Genders
42-60 years
Phase:
NA
Brief Summary
This study will investigate the effects of Functional ankle taping correction on plantar foot ulcer healing in diabetic patients. This study will be carried out at the outpatient clinic of the faculty...
Detailed Description
Design of the study: Randomized controlled trial. Subject's selection: Estimated sample size is 70 subjects the actual sample size will be calculated after pilot study. They will be assigned into tw...
Eligibility Criteria
Inclusion
- The subject selection will be according to the following criteria:
- Undergoing treatment for a Wagner grade II or III diabetic foot ulcer
- Age between 42 and 60 years.
- No systemic diseases such as musculoskeletal disorders, heart diseases, or neurological diseases that can hinder ability to participate in the study
- Not receiving other treatments that could affect wound healing (negative-pressure wound treatment, hyperbaric oxygen treatment, a special wound care product, special wound dressing, or growth factor.
- Not using another complementary treatment method (herbal wound care products and Participating subjects were required to be able to walk 10 m unassisted.
- Absence of protective sensation on the plantar foot as determined using a 10-gram monofilament following criteria from the International Working Group on the Diabetic Foot 2023
- All the patients have active unilateral plantar DFU at least 1cm2 (greatest length x greatest width) and not healed \> 3months duration.
- Never received the same intervention from other researchers and health Professionals..
- • Ability to walk independently for 30 steps or 10 min.
Exclusion
- The potential participants will be excluded if they meet one of the following criteria:
- Patients with inadequate vascular circulation (ankle-brachial pressure index \<0.8 or toe systolic blood pressure \<40 mmHg)
- Patient with skin allergy with generalized osteoporosis, or who had fractures of any bones in the lower extremity.
- Previous ankle pathology or surgery to the lower limb within the last 12 months, current illness or infection, neurological deficits affecting the lower limb and skin conditions or edema affecting the lower limb ,Severe uncontrolled hypertension.
- Pregnant women.
- Un controlled diabetes
- Pedal amputations and arthritis.
- Ulcer developed secondary to acute trauma; ulcer developed secondary to burns.
- Foot deformities included hallux valgus, hallux rigidus, pes planus, pes cavus, low forefoot arch, and hammer toes, Skin callosities, heel fissures, a hypotrophic fat pad, and nail deformities
Key Trial Info
Start Date :
October 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2024
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT06065488
Start Date
October 6 2023
End Date
February 14 2024
Last Update
September 19 2024
Active Locations (1)
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1
Ahmed Mohamed Ahmed Abdelhady
Cairo, Cairo Governorate, Egypt, 11571