Status:
COMPLETED
Wound Healing Effects of HO/03/03 In Patients With Diabetic Neuropathic Plantar and Venous Ulcers, Pilot Study.
Lead Sponsor:
HealOr
Conditions:
Diabetic Foot Ulcer
Venous Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a multicenter pilot study to assess the healing effects of HO/03/03 on diabetic neuropathic plantar and venous ulcers. HO/03/03 action mechanism involves the manipulation of keratinocyte and ...
Detailed Description
This is a multicenter pilot study to assess the healing effects of HO/03/03 on diabetic neuropathic plantar and venous ulcers. Pretreatment phase: During a pretreatment phase that will last up to 14 ...
Eligibility Criteria
Inclusion
- 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
- 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);
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00338923
Start Date
June 1 2006
End Date
May 1 2007
Last Update
August 17 2007
Active Locations (3)
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1
Assaf Harofe Medical Center
Beer Yaakov, Israel, 70300
2
Hadassah Ein Kerem Medical Center
Jerusalem, Israel
3
Kaplan Medical Center
Rehovot, Israel