Wound Healing Effects of HO/03/03 In Patients With Diabetic Neuropathic Plantar and Venous Ulcers, Pilot Study.

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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 fibroblast migration and differentiation at the wound area.

• The primary end point of this study is assessment of safety in treating with HO/03/03 and the efficacy of the drug to promote wound closure of chronic wounds.

• The secondary end points are assessment time to closure and healing rate for the measurement of wound healing progression.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HealOr

Criteria

Inclusion Criteria:

Patients must satisfy all of the following inclusion criteria to be included in the study:

1. be male or female over the age of 18;

2. have a diabetic neuropathic plantar and/or venous ulcer;

3. wound diameter <10cm;

4. wound depth is no more than exposed muscle;

5. have a current physical examination, which reveals no clinically significant abnormalities, except diabetes or diabetic ulcer/wound related condition

6. be available for the entire study period, and be able and willing to adhere to protocol requirements;

7. vascular inflow as measured by Doppler: ABI >= 0.7

8. have a debilitating wound over a period of 1 month prior to the experiment;

9. if female of childbearing potential, must be using a reliable form of birth control;

10. 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:

1. have a body mass index (BMI) > 45;

2. have a glycosylated hemoglobin (HbAlc) > 12.0%;

3. have a history or presence of HIV or a clinically significant cardiac, gastrointestinal, endocrine, neurological, liver, or kidney disease;

4. have any clinically significant illness during the 4 weeks prior to admission into the study, except diabetes type1 or type2;

5. 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;

6. patients on chemotherapy;

7. participation in a clinical study or use of an investigational drug within 30 days prior to admission to this study;

8. are pregnant or lactating;

9. visible bone exposure at wound site;

10. have any signs of clinical infection in the wound (which could be linked to raised body temperature), necrosis, erythema or mild drainage;

11. have any acute illness within 2 weeks prior to Screening;

12. residing in a nursing facility and/or are bed-ridden (unable to come to receive treatment at the clinic);