Venous Ulcer of LegUlcerNCT07763782
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
A study testing Dose-Response Structured CMP Activation in people with Venous Ulcer of Leg, run by MTI University at 1 site in Jordan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Venous Ulcer of Leg
- What is being tested?
- Dose-Response Structured CMP Activation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteJordan
- Study dates
- 1 Oct 2026to 5 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site, 1 recruiting
- Recruiting
Zaytoonah University
Amman, 11118
Ahmed Elfahl, 00244579052, nn_ee_mm_oo@yahoo.com
About this study
Official title: Optimizing Venous Leg Ulcer Healing Via 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.
Read the detailed description
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.
- Conditions
- Venous Ulcer of Leg
- Being tested
- Dose-Response Structured CMP Activation, Active Control
- Keywords
- wound healing, leg ulcer, calf pump
- Medical subject headings
- Varicose Ulcer, Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose-Response Structured CMP ActivationOther
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 ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Dose-Response Structured CMP Activation |
| Group B: Unsupervised Home Walking (Active Control) | Active comparator | Completely independent and self-managed home program Receives: Other: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound healing volume (cm3))
saline injection
Measured: at base line and 12 weeks
wound healing (surface area(cm2)
using Image J software
Measured: at base line and 12 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: at base line and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Oct 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion5 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Ulcer of LegStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763782
- Sponsor's protocol ID
- IRB00014233-94
- Acronym
- Ulcer
- Status last verified
- Oct 2026
- First submitted
- 4 Aug 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Venous Leg Ulcer Healing Via Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
- ClinicalTrials.gov ID
- NCT07763782
- Acronym / sponsor ID
- Ulcer / IRB00014233-94
- Conditions
- Venous Ulcer of Leg
- Keywords
- wound healing, leg ulcer, calf pump
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 5 Feb 2027 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Group A: Dose-Response Structured CMP Activation Strategy | Experimental | Other: Dose-Response Structured CMP ActivationWeeks 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. |
| Group B: Unsupervised Home Walking (Active Control) | Active comparator | Other: Active ControlCompletely independent and self-managed home program |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dose-Response Structured CMP ActivationProgression 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 | Other | Group A: Dose-Response Structured CMP Activation Strategy |
| Active ControlPatients 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. | Other | Group B: Unsupervised Home Walking (Active Control) |
Primary outcome
wound healing volume (cm3))
Time frame: at base line and 12 weeks
saline injection
wound healing (surface area(cm2)
Time frame: at base line and 12 weeks
using Image J software
2 secondary outcomes
Venous Filling Index (VFI) (mL/sec)
Time frame: at baseline and 12 weeks
Ejection Fraction (EF) (%).
Time frame: at base line and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dose-Response Structured CMP Activation in people with Venous Ulcer of Leg, run by MTI University at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound healing volume (cm3)) (time frame: at base line and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.