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Diltiazem Gel Versus Nitroglycerin Ointment in Healing Process of Scleroderma Digital Ulcers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02801305
First Posted: June 15, 2016
Last Update Posted: March 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Shiraz University of Medical Sciences
Information provided by (Responsible Party):
Mohammad Ali Nazarinia, Shiraz University of Medical Sciences
  Purpose
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.

Condition Intervention Phase
Digital Ulcer of Scleroderma Drug: Diltiazem Gel 2% Drug: Nitroglycerin Ointment 2% Drug: Vaseline Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Assessing and Comparing the Effect of Diltiazem Gel Versus Nitroglycerin Ointment in Healing Process of Scleroderma Digital Ulcers.

Resource links provided by NLM:


Further study details as provided by Mohammad Ali Nazarinia, Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • Assessing the effect of topical diltiazem on scleroderma digital ulcers' healing process according to their site and comparing it with topical nitroglycerin [ Time Frame: 10 months ]

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 ]

Enrollment: 90
Study Start Date: June 2016
Study Completion Date: March 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Vaseline
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.
Drug: Vaseline
This is used as the topical placebo agent.
Experimental: Diltiazem Gel 2%
About 30 patients will receive Diltiazem Gel 2% applying 2 times daily for 8 weeks on their digital ulcers.
Drug: Diltiazem Gel 2%
This a topical agent which will be applied on digital ulcers by scleroderma patients.
Other Name: DILTIGEL
Experimental: Nitroglycerin Ointment 2%
About 30 patients will receive nitroglycerin 2% applying 2 times daily for 8 weeks on their digital ulcers.
Drug: Nitroglycerin Ointment 2%
This a topical agent which will be applied on digital ulcers by scleroderma patients.
Other Name: NITROCARD

  Show Detailed Description

  Eligibility

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801305


Locations
Iran, Islamic Republic of
Rheumatology Reseach Center, Shiraz University of Medical Sciences, Shiraz, Iran.
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Mohammad Ali Nazarinia
Shiraz University of Medical Sciences
Investigators
Study Director: Mohammad Ali Nazarinia, M.D. Shiraz Geriatric Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
  More Information

Publications:

Responsible Party: Mohammad Ali Nazarinia, Associate Professor of Rheumatology, Shiraz University of Medical Sciences, Shiraz, Iran., Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02801305     History of Changes
Other Study ID Numbers: 95010111653
First Submitted: June 9, 2016
First Posted: June 15, 2016
Last Update Posted: March 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The individual characteristic and information of the patients will be preserved by the researches and won't be released.

Keywords provided by Mohammad Ali Nazarinia, Shiraz University of Medical Sciences:
Scleroderma
Diltiazem
Nitroglycerin
Topical

Additional relevant MeSH terms:
Ulcer
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Skin Ulcer
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Nitroglycerin
Diltiazem
Petrolatum
Vasodilator Agents
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Emollients
Dermatologic Agents