Efficacy of Pirfenidone Plus MODD in Diabetic Foot Ulcers
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 1/Phase 2

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
    

Detailed description: 
      Subjects will be randomized using a random number table to distribute in the control
      (ketanserin) and the experimental group (PFD+MODD). Demographics data and medical history
      will be registered on a monthly basis, relative ulcer volume will be calculated by measuring
      the longest, widest and deepest ulcer side with sterile flexible graduated ruler. The ulcer
      will be classified according to Wagner scale and photographs will be taken. Ulcer area will
      be washed with aseptic solution (accua aseptic solution™) and a biopsy of around 10-15 mm3
      will be taken from the middle of the ulcer using a scalpel blade. Patients in the
      experimental group will receive topical PFD+MODD (8% gel) three times a day and patients in
      control group will receive ketanserin (2% cream) twice a day. Both groups will apply the
      medicament for six months previous cleansing of the area. Biopsies will be taken at the
      beginning, at month one and month two. After this time, only photographs will be performed,
      and relative ulcer volume will be measured. 5 ml of blood will be taken at the beginning and
      the end of the study to measure general clinical parameters.
    

Intervention name(s): Pirfenidone with MODD; Ketanserin
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): KitosCell Q; 5-methyl-1-phenyl-2(1H)-pyridone with MODD; sufrexal
Intervention MeSH terms: Pirfenidone; Ketanserin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: pirfenidone; Modified oxide diallyl disulfide (MODD); ketanserin; diabetic foot ulcer