Status:
COMPLETED
Efficacy and Safety of Heberprot-P® in Patients With Advanced Diabetic Foot Ulcer in Dasman Diabetes Institute.
Lead Sponsor:
Dasman Diabetes Institute
Collaborating Sponsors:
Cuban Center for Genetic Engineering and Biotechnology
Conditions:
Diabetic Foot
Eligibility:
All Genders
22+ years
Brief Summary
The purpose of this study is to assess the efficacy and safety of the intralesional administration of Heberprot-P® (human recombinant epidermal growth factor) plus the standard treatment in patients w...
Detailed Description
Diabetic foot ulcers constitute an important medical problem in the patients with diabetes mellitus. The epidermal growth factor (EGF) stimulates the proliferation of fibroblasts, keratinocytes and ve...
Eligibility Criteria
Inclusion
- Diagnosis of diabetic foot ulcer,University of Texas Wound Classification AI-AII and CI-CII with or without ischemia at least of 4 weeks of evolution Ulcers with an area between ≥ 2 cm2 or greater (after sharp debridement of free, non-viable, hyperkeratotic and fibrotic tissue) Patients with age than 22 years. Voluntariness of the patient by signing up the informed consent, and written form signed the date prior to study.
Exclusion
- Hemoglobin ≤100 g/L. Patients with a significant acute cardiovascular event (Major Acute Cardiovascular Event) within 3 months prior such as acute myocardial infarction, severe angina pectoris, acute stroke or transient ischemic attack, and/or thrombo-embolism event.
- Patients with chronic uncompensated diseases: diabetic coma, or renal failure (creatinine 200 mmol/L and oligoanuria).
- Antecedents or suspicion of malignant diseases (general physical examination, rectal tact, examination of breast, abdominal ultrasound, thorax radiography and blood hemochemistry).
- Psychiatric diseases that compromise the treatment or the evaluations Infection Pregnancy or breastfeeding.
Key Trial Info
Start Date :
December 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03239457
Start Date
December 1 2015
End Date
February 1 2016
Last Update
August 4 2017
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