Functional Ankle Taping Correction on Plantar Foot Ulcer Healing in Diabetic Patients

NCT06065488 | Completed DMC

• 1 other identifier: P.T.REC/012/004688
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Foot Ulcer

Keywords

plantar foot ulcers; ankle kinesiotap; wound healing; chronic wounds; diabetic patients

Outcome Measures

Primary Outcomes (1)

• Maximum plantar peak pressures of ulcerated foot

  Maximum plantar peak pressures were measured using Tekscan® pressure mat system (Boston , MA). - Patients were given time to familiarise themselves with the protocol. - Prior to testing he mat was calibrated for each individual's mass using mat-Scan® System Research software (Tekscan, Boston, MA). - Once calibration was completed Patient was asked to walk across the plantar pressure mat which placed in the center of walkway - The method has been previously validated and involves each participant taking two steps before landing on the pressure mat. - Trials were excluded and repeated if a participant appeared to target the platform and alter their gait pattern to ensure full contact with the mat - - Collecting data from mat-based Stride way System, a 150 cm long and 60 cm Wide to generate maximum Peake pressure by quantifying the pressure exerted on the force sensors\\ - Direct cont

  Baseline then after 8 weeks

Secondary Outcomes (3)

• Ankle dorsiflexion range of motion of ulcerated foot

  Baseline then after 8 weeks

• Wound surface area by +Wound Desk mobile application

  Baseline then after 8 weeks

• Wound volume assessment

  Baseline then after 8 weeks

Study Arms (2)

1.Group A (Ankle KT group):

EXPERIMENTAL

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)

Device: ankle kinesio tap

2.Group B (Control group Ankle shame KT ):

SHAM COMPARATOR

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)

Device: ankle kinesio tap

Interventions

ankle kinesio tap DEVICE

Kinesio Tape is popular among athletes and non-athletes for its ability to protect, support, and promote activity in overworked muscles. Few people are aware, however, that its healing benefits don't end there. Research studies show that taping ankle with Kinesio Tape actually improves ankle range of motion.

1.Group A (Ankle KT group):; 2.Group B (Control group Ankle shame KT ):

Eligibility Criteria

• Age: 42 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MTI University: lead

Study Sites (1)

Ahmed Mohamed Ahmed Abdelhady

Cairo, Cairo Governorate, 11571, Egypt

Location

Related Publications (2)

• 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.

  PMID: 26342178 BACKGROUND

• 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.

  PMID: 32176438 BACKGROUND

Related Links

• Effectiveness of offloading interventions to heal foot ulcers in persons with diabetes: a systematic review

MeSH Terms

Conditions

Foot Ulcer

Condition Hierarchy (Ancestors)

Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer

Study Officials

• El fahl, ph.d

  faculty of physical therapy .Modern university for information and technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lectrurer of physical therapy for general surgery and dermatology,MTI University

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 4, 2023
• Study Start: October 6, 2023
• Primary Completion: January 26, 2024
• Study Completion: February 14, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)