| Trial name or title |
Assessing and Comparing the Effect of Diltiazem Gel Versus Nitroglycerin Ointment in Healing Process of Scleroderma Digital Ulcers |
| Methods |
Randomized parallel assignment |
| Participants |
90 patients with scleroderma |
| Interventions |
About 60 patients will be considered to be in control group receiving vaseline ointment as the placebo applying 2 times daily on their ulcers for 8 weeks.
Experimental:
Diltiazem Gel 2%
About 30 patients will receive Diltiazem Gel 2% applying 2 times daily for 8 weeks on their digital ulcers.
Experimental: Nitroglycerin Ointment 2%
About 30 patients will receive nitroglycerin 2% applying 2 times daily for 8 weeks on their digital ulcers. |
| Outcomes |
Primary Outcome Measures:
Secondary Outcome Measures:
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 [ Time Frame: 6 months ] To see if the patients, receiving diltiazem gel, develop significantly less numbers of new ulcers during the study [ Time Frame: 6 months ] 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 [ Time Frame: 6 months ] To see if ones receiving nitroglycerin ointment develop significantly less numbers of new ulcers during the study [ Time Frame: 6 months ] To see if ones receiving diltiazem gel have difference in mean diameters of ulcers and numbers of new ones with group receiving nitroglycerin ointment [ Time Frame: 6 months ] To compare the difference in mean diameter of digital ulcers according to their site in each experimental group [ Time Frame: 1 month ]
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| Starting date |
June 2016 |
| Contact information |
Rheumatology Reseach Center, Shiraz University of Medical Sciences, Shiraz, Iran.Shiraz, Fars, Iran, Islamic Republic of |
| Notes |
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