Wound Healing Effects of HO/03/03 In Patients With Diabetic Neuropathic Plantar and Venous Ulcers, Pilot Study.
NCT ID: NCT00338923
Last Updated: 2007-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2006-06-30
2007-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Pretreatment phase: During a pretreatment phase that will last up to 14 days, all patients will receive the conventional treatment once a day at the discretion of the investigator. All wounds will be morphologically monitored by photo documentation daily and measurements of wound area once a week.
Initial study visit: patients will begin treatment after completing all necessary demands in pre-treatment phase or after ruling out of all exclusion criteria. All wounds will be cleaned from previous treatment by surgical debridement and irrigation (saline).
Treatment phase: Following the pre-treatment phase, wounds will be treated topically with HO/03/03 for 30 days. During this 30 day phase, patients will receive daily treatments with HO/03/03 either at home by a certified nurse or at the clinic. Wounds will be monitored by certified medical staff member as well as photo documentation. Then application of the treatment followed by a 15-minute rest. Finally wound will be dressed with a fresh dressing and monitoring of any adverse events.
Patients will be administered HO/03/03 in addition to weight off-load Once a week wounds will be monitored by a physician: wounds size will be determined and documented. Patients will be evaluated for pain sensation at the wound area by filling a pain scoring questionnaire.
Twice during the experiment patients will undergo blood profile, HbA1c, blood glucose, and urine samples testing at the initial and terminating visits.
At the conclusion of the treatment phase the following will be completed:
* A physical examination;
* Collection of all blood and urine samples for clinical laboratory tests (dip sticks);
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment arm
One Arm - Active Compound (HO/03/03)
HO/03/03
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HO/03/03
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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);
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
HealOr
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Micha Rapoport, Dr.
Role: PRINCIPAL_INVESTIGATOR
Assaf Harofe Medical Center
Leon Gilead, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hadassah Ein Kerem Medical Center
Zvi Landau, Dr.
Role: PRINCIPAL_INVESTIGATOR
Kaplan Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Assaf Harofe Medical Center
Beer Yaakov, , Israel
Hadassah Ein Kerem Medical Center
Jerusalem, , Israel
Kaplan Medical Center
Rehovot, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HO-01-05
Identifier Type: -
Identifier Source: org_study_id