Functional Ankle Taping Correction on Plantar Foot Ulcer Healing in Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Maximum plantar peak pressures of ulcerated foot
研究概览
简要总结
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.
详细描述
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:
- 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 ):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 42 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Maximum plantar peak pressures of ulcerated foot
时间窗: Baseline then after 8 weeks
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
次要结局
- 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)
研究者
Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d
lectrurer of physical therapy for general surgery and dermatology,MTI University
MTI University