Efficacy & Safety of Pedyphar Ointment in Diabetic Foot Ulcer Treatment

Inclusion criteria

• Written informed consent signed and dated by study subject.
• Male or Female patients.
• Age is ≥18 years old and ≤ 70 years old.
• Clinical diagnosis of Diabetes Mellitus Type I or II with diabetic foot ulcer. A past history of Diabetes Mellitus and/or the use of anti-diabetic medications for the treatment of Diabetes Mellitus with diabetic foot ulcer are sufficient.
• Presence of 1 or more DFU, less than 15 cm in its biggest diameter, with a Texas University grade ≤ 2 and ≤ grade 2 according to the Wagner Grading system.
• Diabetic foot ulcer has been present for at least 4 weeks and no more than 2 years prior to screening.
• If there is Diabetic Foot Ulcer Infection, It must be:

• Mild ( Presence of ≥ 2 manifestations of inflammation (purulence, or erythema, pain, tenderness, warmth, or indurations),any cellulitis/erythema extending ≤ 2 cm around the ulcer, and infection is limited to the skin or superficial subcutaneous tissues; no other local complications or systemic illness).

Or:

• Moderate Infection (as above) in a patient who is systemically well and metabolically stable but which has ≥1 of the following characteristics: cellulitis extending >2 cm, lymphangitic streaking, spread beneath the superficial fascia, deep-tissue abscess, gangrene, and involvement of muscle, tendon, joint or bone.
• If subject is female and of childbearing potential, she agrees to use a medically acceptable physical barrier method contraceptive during the treatment phase.
• Be willing and able to participate in the study as an outpatient, make the required visits to the study center during the treatment periods, and comply with study requirements.
• Receiving medical care for diabetes.

Exclusion criteria

• DFU with a Texas score >2 and > grade 2 according to the Wagner Grading system.
• Severe Infected DFU with clinical or para-clinical findings suggesting osteomyelitis (Infection in a patient with systemic toxicity or metabolic instability (e.g., fever, chills, tachycardia, hypotension, confusion, vomiting, leukocytosis, acidosis, severe hyperglycemia, or azotemia)
• Clinically defined and documented severe arterial disease.
• History of radiation therapy to the ulcer site.
• If the study subject has Foot Ulcer of no diabetic pathophysiology.
• Receiving corticosteroids or immune suppressive agents.
• History of immune-vascular disease.
• Known hypersensitivity to any component of Pedyphar® or Panthenol.
• Patients undergoing hemodialysis.
• Insufficient blood supply to Lower Limb (ankle-brachial index < 0.9).
• Clinical findings suggesting complicated venous insufficiency of LL. Edema [Hyper pigmentation, Venous dermatitis, Chronic cellulitis, Cutaneous infarction (atrophie blanche), Ulceration]
• Received treatment with any other investigational drug or device within the last 30 days
• Unable to comply with the procedures described in the protocol
• History of moderate to severe ischemic heart disease or any history of congestive heart failure, or has had a myocardial infarction within the previous 6 months.
• Patients with a history of major hematological, renal or hepatic abnormalities.
• Mentally or neurologically disabled patients that are considered not fit to approve their participation in the study.
• Refusal to give informed consent.
• Pregnant or Breastfeeding subjects.