Efficacy of Pirfenidone Plus MODD in Diabetic Foot Ulcers
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
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