Wounds and InjuriesNCT00552643
Study to Evaluate Polyheal-1 in Treatment of Recalcitrant Wounds
A study testing Suspension of polystyrene beads (POLYHEAL 1) and Saline (0.9% NaCl) in people with Wounds and Injuries, run by Polyheal Ltd. at 6 sites in Israel.
Trial summary
The objective of this study is to evaluate the performance of Polyheal-1 compared to Saline in the treatment of recalcitrant wounds including venous, post-operative and post-traumatic chronic wounds with different etiologies including wounds with exposed bone and/or tendons. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Suspension of polystyrene beads (POLYHEAL 1) and Saline (0.9% NaCl)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesIsrael
- Study dates
- May 2008to May 2009
- Phase
- Interventional
- 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
- The patient is 18 years of age and older.
- The patient has at least one recalcitrant wound (venous insufficiency, post- operative and post-traumatic chronic wounds with different etiology including those with open wounds) refractive to healing at least 4 weeks prior to treatment
- Patients defined as grade 4 or below on the granulometer including wounds with exposed bone or tendon.
- Patients will be eligible to participate in the study if their target lesion area of the edges is larger than 15cm2 and smaller than 200 cm2 at baseline in the group A of wounds caused by venous insufficiency or larger than 2cm2 and smaller than 200 cm2 at baseline in the group B of post-operative and post- traumatic chronic wounds with exposed bone, tendon and/or ligaments.
- The patient is expected to be available for the 12 weeks study.
Who cannot join
- Clinically significant arterial vascular disease with ABI index <0.45 if the peripheral pulse is not palpable.
- Wound has necrotic tissue which covers more than 50% of the wound area.
- Neuropathic wounds of diabetic origin.
- Roentgenic (X-ray) evidence of osteomyelitis in target wound in case that the bone is detectable by insertion of wire.
- Diabetic patients with HbA1c >11%
- Presence of a systemic infection or significant local infection such as cellulites, purulent drainage, gangrene, or necrosis at the target wound site, as well as nonviable tissue, sinus tracts or tunnels that cannot be removed by debridement.
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- Previous history of any illness or condition that may impair wound healing, immune deficiency or connective tissue disease (e.g., SLE, AIDS), neurological disease (e.g., multiple sclerosis), dialysis due to renal disease and active hepatic disease.
- Patient is receiving, or has received within one month prior to Visit 1 any treatment known to impair wound healing, including but not limited to: corticosteroids, immuno- suppressive drugs, cytotoxic agents, radiation therapy and chemotherapy.
- Patient has a history of alcohol or drug abuse within the last two years.
- Presence or suspicion of any malignancy.
- Treatment with a dressing containing growth factors or other biological dressings within 15 days, prior to the screening visit.
- Female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception.
- Participation in another clinical trial within 30 days prior to the Screening Visit or during this study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Israel6 sites, 6 recruiting
- Recruiting
Soroka University Medical Center
Beersheba, 84101
David Vigoda, DM, +972 544542476, davidvi@clalit.org.il
David Vigoda, DM
- Recruiting
Hadassah Ein-Kerem Hospital
Jerusalem, 91120
Andr'e Ofek Shlomai, MD, 972-2-6776473, ofek@bgu.ac.il
Andr'e Ofek Shlomai, MD
- Recruiting
Western Galilee Hospital
Nahariya, Post Office Box 21
Leonid Kogan, MD, Ph.D, +972 507887582, Leonid.Kogan@naharia.health.gov.il
Leonid Kogan
- Recruiting
Sourasky Medical Center
Tel Aviv, 64239
Yoav Barnea, MD, (972)-52-466-523, barneay@netvision.net.il
Jerry Weiss, MD
- Recruiting
High Risk Foot Clinic - Maccabi Health Services
Tel Aviv
Eran Tamir, MD, 972-546-247-009, eranetta@012.net.il
Eran Tanir, MD
- Recruiting
Sheba Medical Center
Tel HaShomer, 52620
Eli Regev, MD, +972 544 494 554, erplast@gmail.com
Gavriel Zeilig, MD
About this study
The objective of this study is to evaluate the performance of Polyheal-1 compared to Saline in the treatment of recalcitrant wounds including venous, post-operative and post-traumatic chronic wounds with different etiologies including wounds with exposed bone and/or tendons.
Read the detailed description
Chronic ulcers affect millions of people, and are a growing clinical problem seen most frequently in the elderly. Non-healing or slow healing wounds represent a major health burden and drain on resources, contributing to substantial disability, morbidity, and cost. Wound healing involves a well-orchestrated, complex process leading to repair of injured tissues. Basic principles of good wound care involve removal of necrotic tissue by mechanical, surgical or enzymatic debridement, wound bed preparation, and treatment of infection. In general, wounds that are being appropriately managed show measurable progress within 2-4 weeks. However despite delivering good wound care that includes providing the right dressings, nutritional support, topical care, and offering top-of-the-line support surfaces, wounds often become stagnated. Wounds refractory to treatment for 2-4 weeks are dubbed recalcitrant. Such wounds need sometime some stimuli to start the healing cascade. Polyheal-1, is thought do be potentially useful in triggering the healing process and can be particularly beneficial in stimulating the granulation process in chronic wounds of different etiologies e.g. venous, diabetic wounds, decubitus ulcers and post trauma/surgery complicated wounds. For instance exposed bones and tendons that are particularly difficult to be treated, were previously demonstrated to benefit from stimulation of granulation coverage by application of Polyheal 1.
In this protocol we intent to perform comparative study aimed at comparing performance of Polyheal I to Saline in treatment of recalcitrant wounds of different etiology such as venous and various post-operative wounds including cases were the exposed bone needs granulation coverage. Furthermore, patients with post- operative surgical complications such as sternum or partial foot amputation in diabetic patients will also be a subject of present investigation. Polyheal 1 will be compared to saline as this is the most commonly used treatment intended at keeping the wound moist and enabling progress of granulation and epithelization.
- Conditions
- Wounds and Injuries
- Being tested
- Suspension of polystyrene beads (POLYHEAL 1), Saline (0.9% NaCl)
- Keywords
- Recalcitrant ulcers, Chronic wounds, Venous insufficiency wounds, Ulcers, Exposed bones, Exposed Tendons, Granulation tissue, Polyheal 1, Wound care, Wound healing, Diabetic wounds healing, Post trauma, Post surgery complication, Recalcitrant wounds including venous, post-operative and post-traumatic chronic wounds with different etiologies including wounds with exposed bone and tendon.
- Medical subject headings
- Wounds and Injuries, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suspension of polystyrene beads (POLYHEAL 1)Device
Topical application of Polyheal 1 (15 mL/200cm2 of wound area, TID, 28 days, one cycle
Saline (0.9% NaCl)Device
Also called Physiological solution, 0.9% NaCl
Saline topical application 15 mL/200cm2 of wound area, TID, 28 days, one cycle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment with Polyheal 1 Receives: Device: Suspension of polystyrene beads (POLYHEAL 1) |
| 2 | Active comparator | Saline Receives: Device: Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measures:The primary endpoint will be achievement of at least 75% light red granulation tissue, (grade 7 or 8 on the granulometer),
Measured: 12 weeks
Secondary outcomes (1)
(1) time to complete wound closure measured in weeks, (2) achievement of complete wound closure, measured by number of patients out of total. (3) time to full bone coverage by granulation tissue measured in weeks.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2007 (estimated)
- Study startMay 2008
- Primary completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Polyheal Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gavriel Zeilig, DM, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552643
- Sponsor's protocol ID
- PH1-07-01
- Status last verified
- Oct 2009
- First submitted
- 1 Nov 2007
- Last updated
- 28 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate Polyheal-1 in Treatment of Recalcitrant Wounds
- ClinicalTrials.gov ID
- NCT00552643
- Acronym / sponsor ID
- PH1-07-01
- Conditions
- Wounds and Injuries
- Keywords
- Recalcitrant ulcers, Chronic wounds, Venous insufficiency wounds, Ulcers, Exposed bones, Exposed Tendons, Granulation tissue, Polyheal 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Polyheal Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- May 2009 (estimated)
- First posted
- 2 Nov 2007 (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.
The objective of this study is to evaluate the performance of Polyheal-1 compared to Saline in the treatment of recalcitrant wounds including venous, post-operative and post-traumatic chronic wounds with different etiologies including wounds with exposed bone and/or tendons.
Detailed description
Chronic ulcers affect millions of people, and are a growing clinical problem seen most frequently in the elderly. Non-healing or slow healing wounds represent a major health burden and drain on resources, contributing to substantial disability, morbidity, and cost. Wound healing involves a well-orchestrated, complex process leading to repair of injured tissues. Basic principles of good wound care involve removal of necrotic tissue by mechanical, surgical or enzymatic debridement, wound bed preparation, and treatment of infection. In general, wounds that are being appropriately managed show measurable progress within 2-4 weeks. However despite delivering good wound care that includes providing the right dressings, nutritional support, topical care, and offering top-of-the-line support surfaces, wounds often become stagnated. Wounds refractory to treatment for 2-4 weeks are dubbed recalcitrant. Such wounds need sometime some stimuli to start the healing cascade. Polyheal-1, is thought do be potentially useful in triggering the healing process and can be particularly beneficial in stimulating the granulation process in chronic wounds of different etiologies e.g. venous, diabetic wounds, decubitus ulcers and post trauma/surgery complicated wounds. For instance exposed bones and tendons that are particularly difficult to be treated, were previously demonstrated to benefit from stimulation of granulation coverage by application of Polyheal 1.
In this protocol we intent to perform comparative study aimed at comparing performance of Polyheal I to Saline in treatment of recalcitrant wounds of different etiology such as venous and various post-operative wounds including cases were the exposed bone needs granulation coverage. Furthermore, patients with post- operative surgical complications such as sternum or partial foot amputation in diabetic patients will also be a subject of present investigation. Polyheal 1 will be compared to saline as this is the most commonly used treatment intended at keeping the wound moist and enabling progress of granulation and epithelization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Suspension of polystyrene beads (POLYHEAL 1)Treatment with Polyheal 1 |
| 2 | Active comparator | Device: Saline (0.9% NaCl)Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient is 18 years of age and older.
- The patient has at least one recalcitrant wound (venous insufficiency, post- operative and post-traumatic chronic wounds with different etiology including those with open wounds) refractive to healing at least 4 weeks prior to treatment
- Patients defined as grade 4 or below on the granulometer including wounds with exposed bone or tendon.
- Patients will be eligible to participate in the study if their target lesion area of the edges is larger than 15cm2 and smaller than 200 cm2 at baseline in the group A of wounds caused by venous insufficiency or larger than 2cm2 and smaller than 200 cm2 at baseline in the group B of post-operative and post- traumatic chronic wounds with exposed bone, tendon and/or ligaments.
- The patient is expected to be available for the 12 weeks study.
Key exclusion criteria (13 listed)
- Clinically significant arterial vascular disease with ABI index <0.45 if the peripheral pulse is not palpable.
- Wound has necrotic tissue which covers more than 50% of the wound area.
- Neuropathic wounds of diabetic origin.
- Roentgenic (X-ray) evidence of osteomyelitis in target wound in case that the bone is detectable by insertion of wire.
- Diabetic patients with HbA1c >11%
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 |
|---|---|---|
| Suspension of polystyrene beads (POLYHEAL 1)Topical application of Polyheal 1 (15 mL/200cm2 of wound area, TID, 28 days, one cycle | Device | 1 |
| Saline (0.9% NaCl)Also: Physiological solution, 0.9% NaClSaline topical application 15 mL/200cm2 of wound area, TID, 28 days, one cycle | Device | 2 |
Primary outcome
Primary Outcome Measures:The primary endpoint will be achievement of at least 75% light red granulation tissue, (grade 7 or 8 on the granulometer),
Time frame: 12 weeks
1 secondary outcome
(1) time to complete wound closure measured in weeks, (2) achievement of complete wound closure, measured by number of patients out of total. (3) time to full bone coverage by granulation tissue measured in weeks.
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2009.
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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.
Gavriel Zeilig, DM principal investigator
Sheba Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suspension of polystyrene beads (POLYHEAL 1) and Saline (0.9% NaCl) in people with Wounds and Injuries, run by Polyheal Ltd. at 6 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 5 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: status not confirmed, as of the sponsor's last update on 28 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jordan Rubinson (972-8--9324031, jordanr@polyheal.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measures:The primary endpoint will be achievement of at least 75% light red granulation tissue, (grade 7 or 8 on the granulometer), (time frame: 12 weeks). 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 28 Oct 2009.