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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-06

Study Completion Date

2024-02-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Multi-layer Insoles for a Patient-specific Approach to Shear and Pressure Reduction in Diabetes-related Foot Ulcer

NCT01844479

Diabetic Foot Ulcer Diabetic Foot

COMPLETED NA

Toe Amputations in Patients With Diabetes

NCT05855980

Diabetic Foot Infections Amputation

RECRUITING NA

Offloading Interventions for Diabetic Foot Problems in Upper Egypt

NCT03215953

Diabetic Foot Ulcer

UNKNOWN NA

"Effects of Kinesio Taping in Adjunct to Traditional Physical Therapy on Pain, Range of Motion and Gait Parameters in Patients With Plantar Fasciitis : a Randomized Controlled Trail"

NCT06534866

Plantar Fascitis

RECRUITING NA

Reconstruction of Ankle and Foot Defects

NCT04967040

Foot Injury

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Foot Ulcer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type EXPERIMENTAL

ankle kinesio tap

Intervention Type 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.

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)

Group Type SHAM_COMPARATOR

ankle kinesio tap

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ankle kinesio tap

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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

Minimum Eligible Age

42 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No