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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorMTI University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dose-Response Structured CMP Activation

    Other intervention

    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 intervention

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Group A: Dose-Response Structured CMP Activation StrategyExperimental treatment 1 intervention
Group B: Group B: Unsupervised Home Walking (Active Control)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

wound healing volume (cm3))

saline injection

Time frame
at base line and 12 weeks
2

wound healing (surface area(cm2)

using Image J software

Time frame
at base line and 12 weeks

Secondary outcomes

1

Venous Filling Index (VFI) (mL/sec)

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.

Time frame
at baseline and 12 weeks
2

Ejection Fraction (EF) (%).

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.

Time frame
at base line and 12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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