An interventional study of Dose-Response Structured CMP Activation and Active Control in Venous Ulcer of Leg, sponsored by MTI University. Recruiting at 1 site in Jordan. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by MTI University · Not applicable, Interventional, and Treatment
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.
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.
369 studies on the registry are indexed under Varicose Ulcer; 77 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 309 interventional studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →MTI University is the lead sponsor of 61 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Dose-Response Structured CMP Activation
Completely independent and self-managed home program
Other: Active Control
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
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.
wound healing volume (cm3))
saline injection
Time frame: at base line and 12 weeks
wound healing (surface area(cm2)
using Image J software
Time frame: at base line and 12 weeks
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
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
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Jan 2027, 3 months after the start.
Of 67 non-industry interventional studies with no phase under Varicose Ulcer, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 65. This study's planned 3 months is below that.
Counting every sponsor, half of 133 studies reached it within 28 months; a quarter within 13 and three quarters within 48.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 10, 2026: primary completion Feb 2027 → Jan 2027 and completion Feb 2027 → Jan 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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