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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_14 | Other Identifier | sponsor |
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Digital ulcers (DUs) are an expression of the microangiopathy in patients with scleroderma (SSc). DUs lead to pain and impaired hand use. DUs remain a severe complication for many patients and effective therapy remains elusive. In the present study, the investigators propose to evaluate the efficacy of Sildenafil in DUs healing in a randomized double blind control study in SSc patients.
This is a multicenter, prospective, longitudinal, randomized, comparative, double-blind, 2-parallel-arm, placebo-controlled study aimed to evaluate the efficacy of sildenafil 20 mg TID study on time to healing of DUs in SSc patients with ischaemic DUs.
Approximately 120 patients aged from 18 years and above will be allocated to receive either placebo or sildenafil 20mg TID during 90 days. All potential subjects will present with ischaemic digital ulcers complicating scleroderma. An eligible digital ulcer must be beyond the proximal interphalangeal joint, on finger surface (included periungual ulcers), of ischemic origin according to the physician, and not over subcutaneous calcifications or bone relief.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Actif arm | Active Comparator | Sildenafil 20mg TID during 90 days |
|
| Sugar pill | Placebo Comparator | Placebo pills TID during 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil | Drug | Sildenafil 20 mg TID per os during 90 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| time to healing of ischemic digital ulcers (DUs) in patients with scleroderma treated by sildenafil 20 mg TID versus placebo for 90 days | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the time to healing of ischemic DUs (2 mm at entry and > 1 month and <3 months old) in patients with scleroderma treated by sildenafil 20 mg TID versus placebo for 90 days. | 90 days | |
| To evaluate the change in the number of ischaemic DUs between baseline and day 90. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric HACHULLA, PU-PH | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Nice | Nice | Alpes-Maritimes | 06000 | France | ||
| Hautepierre Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25995322 | Result | Hachulla E, Hatron PY, Carpentier P, Agard C, Chatelus E, Jego P, Mouthon L, Queyrel V, Fauchais AL, Michon-Pasturel U, Jaussaud R, Mathian A, Granel B, Diot E, Farge-Bancel D, Mekinian A, Avouac J, Desmurs-Clavel H, Clerson P; SEDUCE study group. Efficacy of sildenafil on ischaemic digital ulcer healing in systemic sclerosis: the placebo-controlled SEDUCE study. Ann Rheum Dis. 2016 Jun;75(6):1009-15. doi: 10.1136/annrheumdis-2014-207001. Epub 2015 May 20. |
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| placebo |
| Drug |
Placebo pills TID per os during 90 days |
|
| 90 days |
| To evaluate the proportion of patients with complete healing of all DUs present at baseline at day 90. | 90 days |
| To evaluate the proportion of patients with complete healing of all DUs (baseline DUs and new DUs) at day 90. | 90 days |
| To evaluate the proportion of patients who do not develop any new DU after 28 days of treatment with the study drug up to day 90. | 90 days |
| To evaluate the change between baseline and day 90 in hand function and pain. | 90 days |
| To evaluate the proportion of patients with complicated DUs (infection, gangrene, amputation, DU requiring IV prostanoids) over the 90 days period of treatment. | 90 days |
| To evaluate the evolution of the severity of Raynaud's phenomenon between baseline and day 90. | 90 days |
| Strasbourg |
| Bas-Rhin |
| 67098 |
| France |
| Nord Hospital | Marseille | Bouches du Rhone | 13915 | France |
| CHU de Caen | Caen | Calvados | 14033 | France |
| CHU Dijon | Dijon | Côte d'Or | 21000 | France |
| CHU Dupuytren / dermatology | Limoges | Haute Vienne | 87042 | France |
| CHU Dupuytren / Médecine Interne | Limoges | Haute Vienne | 87042 | France |
| CHU de Rennes | Rennes | Ile Et Vilaine | 35203 | France |
| University Hospital, Tours | Tours | Indre-et-Loire | 37000 | France |
| University Hospital, Grenoble | Grenoble | Isère | 38043 | France |
| University Hospital, Nantes | Nantes | Loire-Atlantique | 44000 | France |
| CHU de Reims | Reims | Marne | 51092 | France |
| University Hospital, Fort de France | Fort de France | Martinique | 97 261 | France |
| University Hospital, Lille | Lille | Nord | 59037 | France |
| St Louis Hospital | Paris | PARIS | 75010 | France |
| University Hospital, Rouen | Rouen | Seine-Maritime | 76000 | France |
| University Hospital, Amiens | Amiens | Somme | 80000 | France |
| Hôpital Edouard Herriot | Lyon | 69437 | France |
| Jean Verdier Hospital | Bondy | Île-de-France Region | 93130 | France |
| La Pitié - Salpétriêre Hospital | Paris | Île-de-France Region | 75013 | France |
| Cochin Hospital / Médecine Interne | Paris | Île-de-France Region | 75014 | France |
| Cochin Hospital | Paris | Île-de-France Region | 75014 | France |
| Saint Antoine Hospital | Paris | Île-de-France Region | 75571 | France |
| Groupe Hospitalier Paris Saint Joseph | Paris | Île-de-France Region | 75674 | France |
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D045743 | Scleroderma, Diffuse |
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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