Effects of a Polyethene-Poron Custom Insole Combined With Transcutaneous Electrical Nerve Stimulation on Clinical Outcomes in Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Wound Healing
研究概览
简要总结
Diabetic foot ulcers (DFUs) are one of the serious complications of diabetes, typically resulting from neuropathy or peripheral arterial disease, and can often lead to amputation. It affects approximately 6.3% of people with diabetes globally. In Pakistan, the overall prevalence of DFUs is 16.83%, with a slightly higher rate in females. Diabetic foot ulcers are the main reason for lower extremity amputation (LEA) with non-traumatic origin, hospitalization, healthcare costs, and mortality.
详细描述
Diabetic foot ulcers (DFUs) are a significant complication of diabetes, carry a high risk of amputation and disability, and affect around 6.3% of diabetic patients globally. Risk factors for DFUs include pre-ulcerative lesions, mechanical pressure, restricted mobility, and poor glycemic control. Peripheral neuropathy plays a crucial role in DFU development, causing structural and functional changes in the foot.
Offloading interventions, such as prefabricated orthotics and custom insoles, are essential for preventing DFU development and promoting ulcer healing. Physiotherapy modalities like therapeutic exercise and electrotherapy can assist in tissue repair and pain management. Orthotic management complements rehabilitation efforts, potentially reducing the risk of wound development. Further research on the combined benefits of transcutaneous electrical nerve stimulation (TENS) and customized insoles for DFUs is necessary to enhance clinical outcomes.
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
- Single (Outcomes Assessor)
盲法说明
The outcome assessor will be kept blinded of treatment group.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-60 years old with type 1 and 2 diabetes
- •Both Males and Females
- •Having Foot ulcers in Grade 1 and Grade 2 according to the Wagner Classification
排除标准
- •History of amputation (proximal to the trans-metatarsal joint)
- •Active or inactive Charcot foot
- •Non-constructible peripheral vascular disease secondary to arteriosclerosis (AS)
- •Leg length discrepancy
- •The presence of any allergic condition of the skin,
- •Chronic consumption of opioids,
- •Use of a cardiac pacemaker,
- •Major bone operation,
- •Neurological illness, such as a vestibular disorder with a history of dizziness
- •Mental disorders, which might interfere with the assessment process
- •Dementia or impaired cognitive function
研究组 & 干预措施
Standard Care Only
Participants will receive standard care for diabetic foot ulcers.
干预措施: Standard Care Only (Other)
Custom Insole + Standard Care
Participants will receive a custom insole along with standard care.
干预措施: Custom Insole + Standard Care (Other)
TENS + Custom Insole + Standard Care
Participants will receive TENS therapy, a custom insole, and standard care.
干预措施: TENS + Custom Insole + Standard Care (Other)
TENS + Standard Care
Participants will receive transcutaneous electrical nerve stimulation (TENS) in addition to standard care.
干预措施: TENS plus Standard Care (Other)
结局指标
主要结局
Wound Healing
时间窗: Wound dimensions will be measured at baseline, and change in length and width will be measured at the 4th week, 8th week, and 12th week of the treatment session.
Patients will be assessed for ulcer dimensions by using a simple ruler method. Length and width will be noted using a simple ruler method.
Pain Intensity
时间窗: Pain intensity will be measured at baseline, and change in pain intensity will be measured at 4th week, 8th week, and 12th week.
Pain intensity will be measured using a visual analogue scale. It is an 11-point scale where "0" indicates no pain and "10" indicates the worst possible pain.
Dynamic Balance:
时间窗: Change in status of dynamic balance will be measured at 4th week, at 8th week and 12th week of treatment.
The time up and go (TUG) scale will be used for measuring dynamic balance. A time score of ≤10 seconds is considered normal, and a time of ≥14 seconds has been shown to indicate a high risk of falls.
Wound Healing
时间窗: Wound dimensions will be measured at baseline, and change in length and width will be measured at the 4th week, 8th week, and 12th week of the treatment session.
Patients will be assessed for ulcer dimensions by using a simple ruler method. Length and width will be noted using a simple ruler method.
次要结局
- Risk of fall(Risk of fall will be measured at baseline, and change in status will be measured at the 4th week, 8th week, and 12th week of the treatment session.)
- Toe Muscle Strength(Toe Muscle Strength will be measured at baseline, and change in strength will be measured at the 4th week, 8th week, and 12th week of the treatment session.)
研究者
Ayesha Jamil
Assistant Professor
University of Lahore