Wound Healing Effects of HO/03/03 In Patients With Diabetic Neuropathic Plantar and Venous Ulcers, Pilot Study.
Diabetic Foot Ulcer, Venous Ulcer
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer
Eligibility Criteria
Inclusion Criteria: Patients must satisfy all of the following inclusion criteria to be included in the study: be male or female over the age of 18; have a diabetic neuropathic plantar and/or venous ulcer; wound diameter <10cm; wound depth is no more than exposed muscle; have a current physical examination, which reveals no clinically significant abnormalities, except diabetes or diabetic ulcer/wound related condition be available for the entire study period, and be able and willing to adhere to protocol requirements; vascular inflow as measured by Doppler: ABI >= 0.7 have a debilitating wound over a period of 1 month prior to the experiment; if female of childbearing potential, must be using a reliable form of birth control; provide written informed consent prior to admission into the study. Exclusion Criteria: Patients will be excluded from the study if they meet any of the following exclusion criteria: have a body mass index (BMI) > 45; have a glycosylated hemoglobin (HbAlc) > 12.0%; have a history or presence of HIV or a clinically significant cardiac, gastrointestinal, endocrine, neurological, liver, or kidney disease; have any clinically significant illness during the 4 weeks prior to admission into the study, except diabetes type1 or type2; patients on concomitant medications that alter blood glucose levels (e.g., ACE inhibitors, lipid lowering agents, etc) must be on a stable dosage regimen for at least 4 weeks prior to entry into the study and the dosage must remain stable throughout the study; patients on chemotherapy; participation in a clinical study or use of an investigational drug within 30 days prior to admission to this study; are pregnant or lactating; visible bone exposure at wound site; have any signs of clinical infection in the wound (which could be linked to raised body temperature), necrosis, erythema or mild drainage; have any acute illness within 2 weeks prior to Screening; residing in a nursing facility and/or are bed-ridden (unable to come to receive treatment at the clinic);
Sites / Locations
- Assaf Harofe Medical Center
- Hadassah Ein Kerem Medical Center
- Kaplan Medical Center
Arms of the Study
Arm 1
Active Comparator
Treatment arm
One Arm - Active Compound (HO/03/03)