Efficacy & Safety of Pedyphar Ointment in Diabetic Foot Ulcer Treatment

NCT02379468 | Completed Phase 3

• 1 other identifier: EEPI_ PED_001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Pedyphar® ointment in the healing of foot ulceration in diabetic patients.

Conditions

Diabetic Foot Ulcer

Keywords

Diabetic; Foot; Ulcer

Outcome Measures

Primary Outcomes (2)

• Percentage of diabetic patients with successful healing of foot ulceration in treated with Pedyphar® ointment

  Efficacy

  12 weeks

• Time to complete wound healing within 12 weeks before the end of treatment duration.

  12 weeks

Secondary Outcomes (3)

• To evaluate the healing process of Diabetic foot ulcer using Pedyphar® ointment compared with Panthenol ointment regarding changes of foot ulcer dimensions from baseline visit to the end of the study.

  12 weeks

• To identify the reasons of treatment failure and delayed response

  12 weeks

• To identify adverse events associated with the application of Pedyphar® ointment.

  12 weeks

Study Arms (2)

Pedyphar

EXPERIMENTAL

Ointment

Drug: Pedyphar Ointment

Panthenol

ACTIVE COMPARATOR

Ointment

Drug: Panthenol

Interventions

Pedyphar Ointment DRUG

Pedyphar

Panthenol DRUG

Ointment

Panthenol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Egyptian Pharmaceutical Industries: lead

Study Sites (4)

Alexandria University

Alexandria, Alexandria Governorate, 21500, Egypt

Location

Tanta University

Tanta, Please Select, Egypt

Location

Ain Shames University

Cairo, Egypt

Location

Suez Canal University

Suez, Egypt

Location

MeSH Terms

Conditions

Diabetic Foot; Ulcer

Interventions

dexpanthenol

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Samir H. Asaad, Prof.

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: March 5, 2015
• Study Start: April 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 5, 2015

Record last verified: 2015-02

Locations

EG (4)