Functional Ankle Taping Correction on Plantar Foot Ulcer Healing in

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06065488
Study type	Interventional
Source	MTI University
Contact
Status	Completed
Phase	N/A
Start date	October 6, 2023
Completion date	February 14, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms