Digital Ulcer of Scleroderma Clinical Trial
Official title:
Assessing and Comparing the Effect of Diltiazem Gel Versus Nitroglycerin Ointment in Healing Process of Scleroderma Digital Ulcers.
Verified date | March 2017 |
Source | Shiraz University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Digital ulcers are one of the most prevalent complications of scleroderma (systemic sclerosis). There can be found few surveys on effect of topical agents on healing process of the ulcers. Thus, the aim of this study is to assess and compare the effects of topical diltiazem on SSc digital ulcers versus topical nitroglycerin.
Status | Completed |
Enrollment | 90 |
Est. completion date | March 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Having the criteria of LeRoy. - Having ages between 20-70 years old - Having at least one active digital ulcer Exclusion Criteria: - Having co-morbid diseases such as diabetes, thyroid and cardiovascular diseases - Being smoker, opium addict or alcohol abuser - Ones received inhaled or oral prostanoid in last 3 months, phosphodiesterase inhibitors except for intermittent treatment of erectile dysfunction in last 1 month and the ones received antibiotics 2 weeks prior to the study - The ones with moderate to severe hepatic impairment or increase in aminotransferase levels more than 3 |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Rheumatology Reseach Center, Shiraz University of Medical Sciences, Shiraz, Iran. | Shiraz | Fars |
Lead Sponsor | Collaborator |
---|---|
Mohammad Ali Nazarinia | Shiraz University of Medical Sciences |
Iran, Islamic Republic of,
Abraham S, Steen V. Optimal management of digital ulcers in systemic sclerosis. Ther Clin Risk Manag. 2015 Jun 15;11:939-47. doi: 10.2147/TCRM.S82561. Review. — View Citation
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Bulus H, Varol N, Tas A, Coskun A. Comparison of topical isosorbide mononitrate, topical diltiazem, and their combination in the treatment of chronic anal fissure. Asian J Surg. 2013 Oct;36(4):165-9. doi: 10.1016/j.asjsur.2013.01.010. — View Citation
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Korn JH, Mayes M, Matucci Cerinic M, Rainisio M, Pope J, Hachulla E, Rich E, Carpentier P, Molitor J, Seibold JR, Hsu V, Guillevin L, Chatterjee S, Peter HH, Coppock J, Herrick A, Merkel PA, Simms R, Denton CP, Furst D, Nguyen N, Gaitonde M, Black C. Digital ulcers in systemic sclerosis: prevention by treatment with bosentan, an oral endothelin receptor antagonist. Arthritis Rheum. 2004 Dec;50(12):3985-93. — View Citation
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Ngcozana T, Ong V, Denton CP. Management of digital vasculopathy in systemic sclerosis: benefits of multiple courses of endothelin-1 receptor antagonists. BMJ Case Rep. 2014 Mar 28;2014. pii: bcr2013203174. doi: 10.1136/bcr-2013-203174. — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessing the effect of topical diltiazem on scleroderma digital ulcers' healing process according to their site and comparing it with topical nitroglycerin | 10 months | ||
Secondary | To see if there is any significant difference in mean diameters of scleroderma digital ulcers between patients receiving placebo and ones treated with diltiazem gel | 6 months | ||
Secondary | To see if the patients, receiving diltiazem gel, develop significantly less numbers of new ulcers during the study | 6 months | ||
Secondary | To see if there is any significant difference in mean diameters of scleroderma digital ulcers between patients receiving placebo and ones treated with nitroglycerin ointment | 6 months | ||
Secondary | To see if ones receiving nitroglycerin ointment develop significantly less numbers of new ulcers during the study | 6 months | ||
Secondary | To see if ones receiving diltiazem gel have difference in mean diameters of ulcers and numbers of new ones with group receiving nitroglycerin ointment | 6 months | ||
Secondary | To compare the difference in mean diameter of digital ulcers according to their site in each experimental group | 1 month |