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NCT Number: NCT02632877

Efficacy of Pirfenidone Plus MODD in 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

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Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Molecular Biology and Gene Therapy Institute, Guadalajara, Jalisco, Mexico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pirfenidone with MODD

Drug

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: KitosCell Q, 5-methyl-1-phenyl-2(1H)-pyridone with MODD

Ketanserin

Drug

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: sufrexal

Primary outcomes

  1. assessing change of ulcerated area

    Time frame: 1, 2, 3, 4, 5, and 6 months

    mm3

Secondary outcomes

  1. mRNA levels of collagen type I alpha (COL-1a)

    Time frame: 0, 1 and 2 months

    expression relative units

  2. mRNA levels of Transforming growth factor 1-beta (TGFb-1)

    Time frame: 0, 1 and 2 months

    expression relative units

  3. mRNA levels of Transforming growth factor 3-beta (TGFb-3)

    Time frame: 0, 1 and 2 months

    expression relative units

  4. mRNA levels of Vascular endothelial growth factor (VEGF)

    Time frame: 0, 1 and 2 months

    expression relative units

  5. mRNA levels of Tumor necrosis factor alpha (TNFa)

    Time frame: 0, 1 and 2 months

    expression relative units

  6. mRNA levels of Hypoxia-inducible factor 1-alpha (HIF-1a)

    Time frame: 0, 1 and 2 months

    expression relative units

  7. mRNA levels of Hypoxia-inducible factor 1-betha (HIF-1b)

    Time frame: 0, 1 and 2 months

    expression relative units

  8. mRNA levels of Keratinocyte Growth Factor (KGF)

    Time frame: 0, 1 and 2 months

    expression relative units

  9. mRNA levels of Matrix metalloproteinase-1 (MMP-1)

    Time frame: 0, 1 and 2 months

    expression relative units

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Collaborators

  • Cell Pharma

Registry information

Official study title

Efficacy of Pirfenidone Gel Combined With Modified Oxide Diallyl Disulfide (MODD) Versus Ketanserin for the Treatment of Diabetic Foot Ulcers

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 17, 2015
Registry last updated
Dec 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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