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NCT Number: NCT07763782

Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks

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.

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Key information

Conditions

Venous Ulcer of Leg Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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. Exclusion Criteria
  • 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.

Treatment and study plan

Dose-Response Structured CMP Activation

Other

Progression Protocol (The Dose-Response) Weeks 1-4 (Activation Phase): Focuses on establishing baseline mobility. Ankle ROM Drills: 3 sets of 15 repetitions of passive and active dorsiflexion/plantar flexion stretches utilizing an inelastic stretching strap. Goal: Overcome joint stiffness to reach >10° of passive dorsiflexion. Seated CMP Loading: Seated heel raises with resistive elastic bands (15 repetitions, 4 sets).

Weeks 5-8 (Hypertrophy & Ejection Phase): Focuses on building muscle pump volume.

Standing Closed-Kinetic Chain Exercises: Standing bodyweight heel raises performed on a step to allow a deep negative heel deficit (eccentric loading). 4 sets of 12 repetitions. Incline Ergometry: 15 minutes of continuous stationary cycling or treadmill walking at a 5% to 8% incline to force a natural heel-strike and powerful toe-off phase.

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

Resisted Plantarflexion: Single-leg standing hee

Active Control

Other

Patients were issued a medical-grade wrist-worn pedometer and a matching ankle sensor. The device display was blinded (blacked out) to prevent active self-biasing or behavioral modification based on step count numbers. Data was downloaded retroactively by researchers at bi-weekly clinic visits to measure real-world gait speeds, step counts, total active time, and spatial asymmetries without the patient altering their natural routine. No constraints were placed on gait modifications. If the patient guards their wound by walking flat-footed or shuffling, the behavior is recorded but not corrected, providing a true representation of unguided real-world walking mechanics.

Primary outcomes

  1. wound healing volume (cm3))

    Time frame: at base line and 12 weeks

    saline injection

  2. wound healing (surface area(cm2)

    Time frame: at base line and 12 weeks

    using Image J software

Secondary outcomes

  1. Venous Filling Index (VFI) (mL/sec)

    Time frame: at baseline and 12 weeks

    The Venous Filling Index (VFI) is a quantitative measurement used to assess the severity of venous reflux in patients with venous leg ulcers. It is determined using air plethysmography, which tracks changes in leg volume during and after a series of standardized calf muscle contractions. VFI is calculated as the rate at which blood refills the veins after each contraction, expressed in milliliters per second (mL/sec). A higher VFI indicates more rapid venous refilling, reflecting greater venous insufficiency and reflux. Monitoring VFI allows clinicians to objectively compare the effectiveness of interventions, such as structured calf muscle pump activation strategies versus unsupervised home walks, in improving venous return and supporting ulcer healing.

  2. Ejection Fraction (EF) (%).

    Time frame: at base line and 12 weeks

    To measure Ejection Fraction (EF) as an indicator of calf muscle pump efficacy during a single contraction, use duplex ultrasound or air plethysmography to assess venous volume changes in the lower leg. First, record the baseline venous volume with the patient in a relaxed, supine position. Then, instruct the patient to perform a single, deliberate calf muscle contraction (such as plantarflexion). Immediately measure the post-contraction venous volume. EF is calculated as the percentage of blood ejected from the veins during the contraction: EF (%) = [(baseline volume - post-contraction volume) / baseline volume] × 100. This value quantifies how effectively the calf muscle pump expels venous blood with each contraction.

Sponsors and collaborators

Lead sponsor

MTI University

Other

Registry information

Official study title

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

Acronym: Ulcer

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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