Study of sildenafil to improve walking distance in patients with peripheral arterial disease and intermittent claudication

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What is this study about?

This study focuses on Peripheral Arterial Disease, a condition where blood flow to the legs is reduced, causing pain while walking (known as intermittent claudication). The study will test whether sildenafil citrate can help patients walk longer distances compared to placebo. This medication will be taken orally as tablets for a period of 24 weeks.

The main goal is to determine if sildenafil can improve walking ability in people who experience leg pain that limits their walking distance. Participants will use a treadmill to measure how far they can walk before being stopped by leg pain. The study will track changes in walking distance over time and monitor other aspects of vascular health.

During the study, participants will take either sildenafil or placebo tablets daily. The maximum daily dose of sildenafil will be 140 mg. Throughout the study period, various measurements will be taken to assess walking ability, blood vessel function, and overall health status. The total duration of follow-up will be 48 weeks to evaluate the long-term effects of the treatment.

1 Initial assessment

You will undergo a treadmill test to measure your walking capacity. You will walk until you cannot continue due to leg pain, or for a maximum of 15 minutes.

Your doctor will perform several baseline measurements including endothelial function (blood vessel health), pulmonary function (breathing capacity), and blood pressure tests.

You will complete two questionnaires about your health and quality of life: the SF36 and Peripheral Artery Questionnaire.

2 Treatment period – First 12 weeks

You will receive either sildenafil or a placebo (inactive substance) to take by mouth. Neither you nor your doctor will know which one you are receiving.

After 12 weeks, you will repeat the treadmill test, questionnaires, and other health measurements.

3 Treatment period – Week 24

At week 24, you will undergo another complete assessment including the treadmill test, questionnaires, and all health measurements.

Your walking capacity will be compared to your initial test to measure any improvements.

4 Final assessment – Week 48

The final evaluation will take place at week 48.

You will complete the final treadmill test, questionnaires, and health measurements.

Your doctor will assess if you have experienced any significant health events during the study period.

5 Monitoring throughout the study

Your doctor will monitor your health and any symptoms you experience throughout the 48-week period.

The study will track how well you follow the treatment plan and any side effects you may experience.

Who Can Join the Study?

Must be 18 years or older
Must have peripheral artery disease confirmed by at least one of these tests:
– Ankle-brachial index (ABI) of 0.90 or less
– Toe-brachial index (TBI) of 0.70 or less
– Decrease in ABI by 18.5% after exercise
– Specific exercise test showing reduced oxygen levels in tissues
Must have stable limiting claudication (pain in legs during walking that forces you to stop) despite receiving standard medical treatment for at least 4 weeks, including:
– Blood-thinning medications
– Cholesterol-lowering drugs
– Blood pressure medications
– Regular walking advice
Must be able to walk no more than 500 meters during a treadmill test
Must be registered with a social security agency
Must be able to understand the study requirements and provide written informed consent
Both men and women may participate

Who Cannot Join the Study?

Age below 18 or above 80 years old
History of severe heart problems or recent heart attack (within last 6 months)
Uncontrolled high blood pressure (blood pressure above 170/100 mmHg)
Current use of nitrate medications (medications for chest pain or heart conditions)
Severe kidney or liver disease
History of stroke in the past 6 months
Active bleeding disorders
Current treatment with medications that interact with sildenafil
Pregnancy or breastfeeding
Participation in other clinical trials within the last 30 days
Known allergic reactions to sildenafil or similar medications
Severe vision problems, including a condition called retinitis pigmentosa (a genetic disorder affecting the eyes)
Active stomach ulcers
Inability to walk independently
Mental conditions that could affect the ability to provide informed consent

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble	Grenoble	France
Centre Hospitalier De Cholet	Cholet	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Glekyu Hzzuxgvouwy Utqmmbdqpcdol Pgbxe Pzbcaqjnuqj Eo Nnnrfwcthitw	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	24.11.2021

Trial locations

Investigated drugs:

Sildenafil is a medication that helps improve blood flow throughout the body. In this trial, it is being studied for its potential to help people with peripheral arterial disease walk longer distances without pain. While this medication is commonly known for treating erectile dysfunction, researchers are investigating its ability to improve circulation in leg arteries, which could help patients who experience pain and difficulty walking due to poor blood flow in their legs.

Peripheral Arterial Disease – A circulatory condition where narrowed arteries reduce blood flow to the limbs, most commonly affecting the legs. The condition develops gradually as arteries become hardened and narrowed due to the buildup of fatty deposits called plaque on artery walls. The reduced blood flow causes pain during walking (claudication), which typically subsides with rest. As the disease progresses, patients may experience leg pain even at rest, along with numbness and coldness in the lower legs and feet. The condition can also lead to slow-healing sores on the legs and feet.

Trial ID:

2024-516429-30-00

Protocol code:

35RC17_8844_VIRTUOSE

NCT ID:

NCT03686306

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of sildenafil to improve walking distance in patients with peripheral arterial disease and intermittent claudication

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?