Clinical trial NCT06065488: Functional Ankle Taping Correction on Plantar Foot Ulcer Healing in Diabetic Patients
Official title: Functional Ankle Taping Correction on Plantar Foot Ulcer Healing in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot Ulcer
Keywords: plantar foot ulcers
ankle kinesiotap
wound healing
chronic wounds
diabetic patients
Lead sponsor: MTI University
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 74
Sex: ALL
Minimum age (years): 42
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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 of physical therapy, modern university for technology and information, Om El masryeen general Hospital and El Rahma - private clinic.

All participants will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data.

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 two equal groups:

1. Group A (Ankle KT group):

   This group includes 35 patients with chronic unhealed plantar foot ulcers for longer than three months; they will receive functional ankle taping, medical treatment, and dressing according their cases. The tape was applied for 5 days and then removed for 1 day to allow skin perspiration. This process was repeated for successive 8 weeks. The patient was instructed to avoid vigorous activities for 30 min, which is required for the glue to become fully activated (Andrýsková et al., 2020)
2. Group B (Control group Ankle shame KT ):

This group includes 35 patients with chronic unhealed plantar foot ulcers for longer than three months. Shame taping group, a placebo taping method considered to be ineffective ( not from insertion to origin of muscles) with the same material without tension , they will receive medical treatment, and dressing according their cases The shame tape was applied for 5 days and then removed for 1 day to allow skin perspiration. This process was repeated for successive 8 weeks. The patient was instructed to avoid vigorous activities for 30 min, which is required for the glue to become fully activated. (Andrýsková et al., 2020) Patients were followed for 8 weeks or until ulcer healing, whichever came first. The protocol was designed according to the fundamental treatment principal of the expert panel to the 2022 American Diabetic Association consensus development conference on diabetic foot wound care.

Eligibility criteria: 1. Inclusion Criteria:

   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.
2. Exclusion Criteria:

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

Primary outcomes:
measure: Maximum plantar peak pressures of ulcerated foot
timeFrame: Baseline then after 8 weeks
Secondary outcomes:
measure: Ankle dorsiflexion range of motion of ulcerated foot
timeFrame: Baseline then after 8 weeks
measure: Wound surface area by +Wound Desk mobile application
timeFrame: Baseline then after 8 weeks
measure: Wound volume assessment
timeFrame: Baseline then after 8 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Mohamed Ahmed Abdelhady
Study officials:
affiliation: faculty of physical therapy .Modern university for information and technology
name: El fahl, ph.d
role: STUDY_CHAIR
References:
citation: Bus SA, van Deursen RW, Armstrong DG, Lewis JE, Caravaggi CF, Cavanagh PR; International Working Group on the Diabetic Foot. Footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in patients with diabetes: a systematic review. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:99-118. doi: 10.1002/dmrr.2702.
citation: Lazzarini PA, Jarl G, Gooday C, Viswanathan V, Caravaggi CF, Armstrong DG, Bus SA. Effectiveness of offloading interventions to heal foot ulcers in persons with diabetes: a systematic review. Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1(Suppl 1):e3275. doi: 10.1002/dmrr.3275.