Diabetic Foot UlcerPhase 1NCT00338923
Wound Healing Effects of HO/03/03 In Patients With Diabetic Neuropathic Plantar and Venous Ulcers, Pilot Study.
A Phase 1 study testing HO/03/03 in people with Diabetic Foot Ulcer and Venous Ulcer, run by HealOr at 3 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Venous Ulcer
- What is being tested?
- HO/03/03
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesIsrael
- Study dates
- Jun 2006to May 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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;
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- 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);
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Assaf Harofe Medical Center
Beer Yaakov, 70300
Hadassah Ein Kerem Medical Center
Jerusalem
Kaplan Medical Center
Rehovot
About this study
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.
Read the 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 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
- Diabetic Foot Ulcer, Venous Ulcer
- Being tested
- HO/03/03
- Medical subject headings
- Diabetic Foot, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HO/03/03Drug
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Active comparator | One Arm - Active Compound (HO/03/03) Receives: Drug: HO/03/03 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: Treatment Period
Secondary outcomes (1)
Time to Heal & Rate of Healing
Measured: Treatment Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startJun 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealOr
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Micha Rapoport, Dr., Principal investigator, Assaf Harofe Medical CenterLeon Gilead, Dr., Principal investigator, Hadassah Ein Kerem Medical CenterZvi Landau, Dr., Principal investigator, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338923
- Sponsor's protocol ID
- HO-01-05
- Status last verified
- Aug 2007
- First submitted
- 19 Jun 2006
- Last updated
- 17 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Healing Effects of HO/03/03 In Patients With Diabetic Neuropathic Plantar and Venous Ulcers, Pilot Study.
- ClinicalTrials.gov ID
- NCT00338923
- Acronym / sponsor ID
- HO-01-05
- Conditions
- Diabetic Foot Ulcer, Venous Ulcer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- HealOrIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Study completion
- May 2007 (actual)
- First posted
- 20 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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);
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Active comparator | Drug: HO/03/03One Arm - Active Compound (HO/03/03) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HO/03/03 | Drug | Treatment arm |
Primary outcome
Safety
Time frame: Treatment Period
1 secondary outcome
Time to Heal & Rate of Healing
Time frame: Treatment Period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2007.
Related trials for Diabetic Foot Ulcer
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Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Micha Rapoport, Dr. principal investigator
Assaf Harofe Medical Center
Leon Gilead, Dr. principal investigator
Hadassah Ein Kerem Medical Center
Zvi Landau, Dr. principal investigator
Kaplan Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HO/03/03 in people with Diabetic Foot Ulcer and Venous Ulcer, run by HealOr at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Treatment Period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2007.