Efficacy of Pirfenidone Plus MODD in Diabetic Foot Ulcers
|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.|
|ClinicalTrials.gov Identifier: NCT02632877|
Recruitment Status : Completed
First Posted : December 17, 2015
Last Update Posted : December 17, 2015
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
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcer||Drug: Pirfenidone with MODD Drug: Ketanserin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy of Pirfenidone Gel Combined With Modified Oxide Diallyl Disulfide (MODD) Versus Ketanserin for the Treatment of Diabetic Foot Ulcers|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||December 2015|
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.
Drug: Pirfenidone with MODD
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.
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 Name: sufrexal
- assessing change of ulcerated area [ Time Frame: 1, 2, 3, 4, 5, and 6 months ]mm3
- mRNA levels of collagen type I alpha (COL-1a) [ Time Frame: 0, 1 and 2 months ]expression relative units
- mRNA levels of Transforming growth factor 1-beta (TGFb-1) [ Time Frame: 0, 1 and 2 months ]expression relative units
- mRNA levels of Transforming growth factor 3-beta (TGFb-3) [ Time Frame: 0, 1 and 2 months ]expression relative units
- mRNA levels of Vascular endothelial growth factor (VEGF) [ Time Frame: 0, 1 and 2 months ]expression relative units
- mRNA levels of Tumor necrosis factor alpha (TNFa) [ Time Frame: 0, 1 and 2 months ]expression relative units
- mRNA levels of Hypoxia-inducible factor 1-alpha (HIF-1a) [ Time Frame: 0, 1 and 2 months ]expression relative units
- mRNA levels of Hypoxia-inducible factor 1-betha (HIF-1b) [ Time Frame: 0, 1 and 2 months ]expression relative units
- mRNA levels of Keratinocyte Growth Factor (KGF) [ Time Frame: 0, 1 and 2 months ]expression relative units
- mRNA levels of Matrix metalloproteinase-1 (MMP-1) [ Time Frame: 0, 1 and 2 months ]expression relative units
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): NCT02632877
|Molecular Biology and Gene Therapy Institute|
|Guadalajara, Jalisco, Mexico, 44340|
|Hospital Valentín Gómez Farías|
|Zapopan, Jalisco, Mexico|
|Study Director:||Juan Armendariz-Borunda, PhD, FAASLD||University of Guadalajara|