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临床试验/NCT07763782
NCT07763782尚未招募不适用

Optimizing Venous Leg Ulcer Healing Via Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks

MTI University0 个研究点目标入组 80 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
主要终点
wound healing volume (cm3))

研究概览

简要总结

investigates the comparative effectiveness of two interventions aimed at promoting the healing of venous leg ulcers-a common chronic condition characterized by impaired venous return and poor wound healing in the lower extremities. The research explores whether structured and supervised calf muscle pump activation exercises, delivered with individualized dose-response protocols, can enhance venous return and improve ulcer healing outcomes more effectively than traditional recommendations for unsupervised home walking. The structured intervention likely involves targeted exercises designed to optimize the activation and function of the calf muscle pump, which is crucial for facilitating blood flow from the legs back to the heart. In contrast, the unsupervised home walks represent a less controlled, patient-led approach often prescribed in clinical practice. By comparing these approaches, the study seeks to determine if a more scientific, structured exercise regimen tailored to each patient's response yields superior healing rates, better compliance, and improved patient quality of life. Ultimately, the findings may inform best practices for physical therapy and rehabilitation strategies in the management of venous leg ulcers, potentially leading to more personalized and effective treatment protocols in clinical and home settings.

详细描述

The research aims to determine whether a structured, dose-response regimen of calf muscle pump activation exercises, which are specifically designed and supervised to maximize venous return in the lower limbs, can enhance ulcer healing rates more effectively than the traditional recommendation of unsupervised home walking. Participants are divided into two groups: one receives guided interventions with tailored exercise frequency, duration, and intensity to systematically activate the calf muscle pump, while the control group is advised to perform regular home walks without supervision or specific guidance. The study meticulously measures healing outcomes, adherence, vascular function, and patient quality of life to assess the true impact of structured exercise versus informal activity. By analyzing these variables, the research seeks to provide evidence-based recommendations for optimizing therapeutic strategies in the management of venous leg ulcers, potentially shifting clinical practice toward more prescriptive and individualized physical activity guidelines, and highlighting the importance of targeted exercise science in post-secondary physical education and rehabilitation curricula.

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, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age (ge 20 - 60) years with a confirmed, non-healing VLU (present for \(>6\) weeks).
  • Ulcer surface area between \(2 \text{ cm}^2\) and \(20 \text{ cm}^2\).
  • Ankle-Brachial Index (ABI) \(\ge 0.8\), ensuring adequate arterial perfusion.
  • Able to provide informed consent and comply with follow-up appointments.

排除标准

  • Severe, uncompensated congestive heart failure (NYHA Class III or IV).
  • Active local wound infection or systemic osteomyelitis.
  • Deep vein thrombosis (DVT) diagnosed within the past 3 months.
  • Severe osteoarthritic limitations rendering ankle movement impossible.

研究组 & 干预措施

Group A: Dose-Response Structured CMP Activation Strategy

Experimental

Weeks 1-4 (Activation Phase): Focuses on establishing baseline mobility. Weeks 5-8 (Hypertrophy & Ejection Phase): Focuses on building muscle pump volume.

Weeks 9-12 (Power & Hemodynamic Clearance Phase): Focuses on clearing pooled blood under high pressure.

干预措施: Dose-Response Structured CMP Activation (Other)

Group B: Unsupervised Home Walking (Active Control)

Active Comparator

Completely independent and self-managed home program

干预措施: Active Control (Other)

结局指标

主要结局

wound healing volume (cm3))

时间窗: at base line and 12 weeks

saline injection

wound healing (surface area(cm2)

时间窗: at base line and 12 weeks

using Image J software

次要结局

  • Venous Filling Index (VFI) (mL/sec)(at baseline and 12 weeks)
  • Ejection Fraction (EF) (%).(at base line and 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d

assistant professor

MTI University

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