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

NCT00338923 | Completed Phase 1

• 1 other identifier: HO-01-05
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Diabetic Foot Ulcer; Venous Ulcer

Outcome Measures

Primary Outcomes (1)

• Safety

  Treatment Period

Secondary Outcomes (1)

• Time to Heal & Rate of Healing

  Treatment Period

Study Arms (1)

Treatment arm

ACTIVE COMPARATOR

One Arm - Active Compound (HO/03/03)

Drug: HO/03/03

Interventions

HO/03/03 DRUG

Treatment arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• HealOr: lead

Study Sites (3)

Assaf Harofe Medical Center

Beer Yaakov, 70300, Israel

Location

Hadassah Ein Kerem Medical Center

Jerusalem, Israel

Location

Kaplan Medical Center

Rehovot, Israel

Location

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer

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; Varicose Veins

Study Officials

• Micha Rapoport, Dr.

  Assaf Harofe Medical Center

  PRINCIPAL INVESTIGATOR

• Leon Gilead, Dr.

  Hadassah Ein Kerem Medical Center

  PRINCIPAL INVESTIGATOR

• Zvi Landau, Dr.

  Kaplan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 20, 2006
• Study Start: June 1, 2006
• Study Completion: May 1, 2007
• Last Updated: August 17, 2007

Record last verified: 2007-08

Locations

IL (3)