Could a daily pill ease leg pain and swelling from vein disease?

NCT ID NCT07684833

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether a daily tablet of CLR-07-23 (heparan sulfate) can reduce symptoms of chronic venous disease, such as leg pain, itching, swelling, and night cramps. The study includes adults aged 18 to 80 with mild to moderate vein disease. Participants take either the active tablet or a placebo for one year, and researchers measure changes in symptom severity using a standard clinical score.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
heparan sulfate (CLR-07-23) prolonged-release tablets
What this could lead to
If effective, this treatment could reduce common symptoms of chronic venous disease, such as leg pain, swelling, and cramps, improving daily comfort and mobility.
What could go wrong
This is a phase 3 trial, but the drug may not prove more effective than placebo. Possible side effects are not yet fully known, and results may not apply to all patients with venous disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 174 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants with an age ≥ 18 and ≤ 80 years * Diagnosed primary venous disease of the lower limbs in stage C2 - C5 according to the CEAP classification, involvement of the venous system of the lower limbs is verified by duplex ultrasonography * Presence of objective signs and subjective symptoms of the disease (classified according to rVCSS score ≥ 4) * Participants not using or planning to use compression therapy by their own decision * Provision of written informed consent as approved by the Ethics Committee (EC). Exclusion Criteria: * Use of a venoactive drug in the last month * Regular use of compression therapy or use of mechanical devices for reduction of edema in the last month * Heart Failure (NYHA class III and IV), congestive heart failure with peripheral edema * eGFR \< 30 mL/min/1.73 m² at screening or chronic kidney disease documented in the medical history * ALT or AST more than 3 times the upper limit of normal range at screening or advanced liver disease documented in the medical history * Deep venous thrombosis lower limb thrombosis and / or documented residual venous obstruction or deep venous reflux due to post-thrombotic alterations in the deep venous system * Superficial venous thrombosis of the lower limbs in the previous 6 months * Congenital venous/lymphatic malformation * Neuropathy of any aetiology * Diabetic foot syndrome * Refractory (uncontrollable) hypertension (inability to therapeutically achieve a systolic blood pressure ≤ 160 mmHg or a diastolic blood pressure ≤ 100 mmHg) * Symptomatic ischemic disease of lower limbs * Lymphoedema: primary, posttraumatic, postoperative, post-radiation, malignant * Manual/instrumental lymphatic drainage in the last 3 months * Invasive procedure on the lower limbs in the last 6 months * Trauma of the lower extremity that has not fully healed * Use of oral/parenteral anticoagulants * Use of dual antiplatelet therapy * Use of loop diuretics * Use of oestrogens or progesterone and its derivates -. Use of oral/parental corticosteroids in the last 6 weeks * Chronic pain treatment ≥ 14 days * Use of psychopharmaceuticals affecting fluid retention (antipsychotics, combined antidepressants) * Severe obesity (BMI \> 40 kg/m2) * Participants with active malignant disease or malignant disease in remission for less than 5 years * Myeloproliferative or immune disorders * Contraindications to the IMP/Placebo administration * Hypersensitivity to the IMP/Placebo excipients. General Conditions * Pregnant or breastfeeding women * Women of child-bearing potential not using at least one effective contraceptive method for the entire trial * Participation in other investigational drug or device clinical trials within 30 days prior to study screening -. Participants legally or mentally incapacitated unable to give informed consent for the participation in this trial * Participants unable or unwilling to comply with appointments or all protocol requirements.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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