- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02632877
Efficacy of Pirfenidone Plus MODD in Diabetic Foot Ulcers
Efficacy of Pirfenidone Gel Combined With Modified Oxide Diallyl Disulfide (MODD) Versus Ketanserin for the Treatment of Diabetic Foot Ulcers
Diabetic foot ulcers (DFU) develop because of the interaction of predisposing factors like neuropathy, angiopathy and infection. Likewise, environmental factors like lesion hygiene, diet and life style.
DFU results as a complication in diabetic patients and it is the most common cause of non-traumatic foot amputation in people older than 50 years. Foot amputation decreases patients´ quality of life since only 33% of them will continue walking with the use of a prothesis.
However, 30% of patients subjected to amputation will die in the first year after surgery and by the 5th year, post-surgery 50% of them will need the amputation of the remaining body extremity.
According to the World Foundation for Diabetes, in Latin America there are 18 million people with Diabetes Mellitus Type 2 (DM2). This number will increase in the next 20 years to 30 million.
Medical expenses for diabetic patients are calculated to be around 8,000 million dollars, annually. In Mexico, according to the Mexican Federation for Diabetes there are 6.5-10 millions of diabetic patients.
Amputation due to DFU complications has many social and economic implications. In Mexico in 2011 diabetes mellitus complications were the principal cause of death in the institute of mexican social security (IMSS) population.
On the other hand, 5-methyl-1-phenyl-2-(1h)-pyridone (PFD) is considered an anti-inflammatory drug that promotes re-epithelization due to fibroblast stimulation, angiogenesis and vasculogenesis during tissue remodeling.
According to this, the investigators believe that PFD could play an important role in DFU resolution and for this reason, the investigators consider necessary to analyze the efficacy of 5-methyl-1-phenyl-2-(1h)-pyridone for the treatment of DFU since it has showed improvement in chronic skin ulcers in pilot studies.
Nowadays, DFU treatment includes management of metabolism, angiopathy and neuropathy along with broad-spectrum antibiotic therapy. However, several reports indicate it is insufficient for and adequate control of diabetic patients.
Then, it is important to develop efficient therapies for the treatment of DFU. In this context, Ketanserin (Sufrexal™) is a drug to induce scar formation. It has been demonstrated to decrease peripheral vascular resistance, platelet aggregation and improves hemorheologic parameters.
Topical administration of ketanserin has showed beneficial effects in inflammation, granulation and epithelization.
Since these two drugs have showed beneficial effects in tissue regeneration, the investigators believe it is important to compare their safety and efficacy for the treatment of DFU
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Jalisco
-
Guadalajara, Jalisco, Mexico, 44340
- Molecular Biology and Gene Therapy Institute
-
Zapopan, Jalisco, Mexico
- Hospital Valentín Gómez Farías
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnostic for diabetic foot ulcer grade I to II according to Wagner scale
- Volunteer patients that accept to sign an informed consent letter
- Patients that agree to fill a clinical history, access to physical exploration and biochemical analysis samples, ulcer biopsy and photodocumentation of ulcer progress.
- Patients willing to sign a compliance letter to apply treatment as indicated by the principal investigator.
Exclusion Criteria:
- Patients with another chronic disease like venous insufficiency or cardiopathy.
- Patients with severe arteriopathy that do not have possibility to direct revascularization like the ones subject to graft tissue, plastics or stents positioning.
- Patients with severe arteriopathy that do not have possibility to indirect vascularization like the ones subject to sympathectomy .
Elimination criteria:
- Patients without adherence to treatment
- Patients that miss medical appointments
- Patients that show allergy to the 8% 5-methyl-1-phenyl-2-(1h pyridone gel and MODD or any of its components.
- Patients allergic to the 2% ketanserin gel or any of its components.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pirfenidone with MODD
Active ingredients: Pirfenidone 8% with modified oxide diallyl disulfide (MODD) 0.016%. Dosage form: gel. Dosage: standar finger tip unit (0.5g for an area of 100 to 120 square centimeters). Frequency and duration: topically applied every eight hours for 6 months. |
Patients with diabetic foot ulcer will be treated three times a day with a smooth layer (standar finger tip unit 0.5g for an area of 100 to 120 square centimeters) of KitosCell Q (Pirfenidone with MODD) in form of gel and the wound will be covered with a bandage.
Other Names:
|
Active Comparator: Ketanserin
Active ingredients: Ketanserin 2%. Dosage form: gel. Dosage: standar finger tip unit (0.5g for an area of 100 to 120 square centimeters). Frequency and duration: topically applied every 12 hours for 6 months. |
Patients will be administered ketanserin twice a day usign the standar finger tip unit (0.5g for an area of 100 to 120 square centimeters) and the wound will be covered with a bandage.
This arm is a control for evolution of diabetic foot ulcer.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
assessing change of ulcerated area
Time Frame: 1, 2, 3, 4, 5, and 6 months
|
mm3
|
1, 2, 3, 4, 5, and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mRNA levels of collagen type I alpha (COL-1a)
Time Frame: 0, 1 and 2 months
|
expression relative units
|
0, 1 and 2 months
|
mRNA levels of Transforming growth factor 1-beta (TGFb-1)
Time Frame: 0, 1 and 2 months
|
expression relative units
|
0, 1 and 2 months
|
mRNA levels of Transforming growth factor 3-beta (TGFb-3)
Time Frame: 0, 1 and 2 months
|
expression relative units
|
0, 1 and 2 months
|
mRNA levels of Vascular endothelial growth factor (VEGF)
Time Frame: 0, 1 and 2 months
|
expression relative units
|
0, 1 and 2 months
|
mRNA levels of Tumor necrosis factor alpha (TNFa)
Time Frame: 0, 1 and 2 months
|
expression relative units
|
0, 1 and 2 months
|
mRNA levels of Hypoxia-inducible factor 1-alpha (HIF-1a)
Time Frame: 0, 1 and 2 months
|
expression relative units
|
0, 1 and 2 months
|
mRNA levels of Hypoxia-inducible factor 1-betha (HIF-1b)
Time Frame: 0, 1 and 2 months
|
expression relative units
|
0, 1 and 2 months
|
mRNA levels of Keratinocyte Growth Factor (KGF)
Time Frame: 0, 1 and 2 months
|
expression relative units
|
0, 1 and 2 months
|
mRNA levels of Matrix metalloproteinase-1 (MMP-1)
Time Frame: 0, 1 and 2 months
|
expression relative units
|
0, 1 and 2 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Juan Armendariz-Borunda, PhD, FAASLD, University of Guadalajara
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Leg Ulcer
- Skin Ulcer
- Diabetes Complications
- Diabetes Mellitus
- Diabetic Neuropathies
- Foot Diseases
- Diabetic Foot
- Foot Ulcer
- Ulcer
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Platelet Aggregation Inhibitors
- Antineoplastic Agents
- Serotonin Agents
- Serotonin Antagonists
- Pirfenidone
- Ketanserin
Other Study ID Numbers
- IBMMTG.14
- ISSSTE/CEI/TR/2014/01 (Other Identifier: ISSSTE)
- Institute of Molecular Biology (Other Identifier: University of Guadalajara)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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