Chronic WoundPhase 1/2NCT01429519
Efficacy of RPh201 Applied Topically for the Treatment of Hard to Heal Chronic Ulcerated Wounds
A Phase 1/2 study testing RPh201, botanical drug product in people with Chronic Wound, run by Regenera Pharma Ltd at 1 site in Israel.
Trial summary
The study objectives are to evaluate safety and efficacy of topical administration of RPh201 oil solution (botanical extract) for treatment of patients with hard to heal chronic ulcerated wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Wound
- What is being tested?
- RPh201, botanical drug product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2011to Dec 2012
- Phase
- Phase 1/2
- 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
- Participants, either men or women are ≥ 18 years of age.
- Patients must have at least one hard to heal wound of different etiologies (venous insufficiency, lymphatic insufficiency, neuropathic wounds or diabetic ulcers, post- operative and post-traumatic chronic wounds) located on the leg shin or foot.
- The wound is refractive to healing at least 4 weeks prior to treatment, although treated by routine practice.
- Wound area size is in the range of: 3 - 36 square centimeters.
- Patients defined as grade C or above on the granulometer scale (see section 6.5.1).
- Participants understand the nature of the procedure and provide written informed consent prior to any study procedure.
- Women of child bearing potential must use adequate birth-control precautions.
Who cannot join
- Clinically significant arterial vascular disease with ABI index <0.45 if the peripheral pulse is not palpable, or flatted PVR in case of non palpable arteries.
- Clinical evidence for presence of infection in the soft tissue, joint and/or bone (osteomyelitis).
- Wound has Non-viable tissue which covers more than 50% of the wound area.
- Patients with skin disorders unrelated to the ulcer that are presented adjacent to the wound.
- The wound penetrates into deep organs and involves bone, tendon or joint
- Wound with sinus tracts
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- Patients are receiving, or have received within one month prior to enrollment any treatment known to impair wound healing, including but not limited to: immuno-suppressive drugs, cytotoxic agents, radiation therapy and chemotherapy.
- Treatment with a dressing containing growth factors or other biological dressings within 15 days, prior to the screening visit.
- Patients that have a history of alcohol or drug abuse within the last two years.
- 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.
- Clinically significant and/or uncontrolled condition or other significant medical disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A PRELIMINARY OPEN CLINICAL STUDY, TO ASSESS THE SAFETY AND EFFICACY OF RPh201 APPLIED TOPICALLY FOR THE TREATMENT OF HARD TO HEAL CHRONIC ULCERATED WOUNDS
The study objectives are to evaluate safety and efficacy of topical administration of RPh201 oil solution (botanical extract) for treatment of patients with hard to heal chronic ulcerated wounds.
Read the detailed description
The study objectives are to evaluate safety and efficacy, of topical administration of RPh201 for treatment of patients with hard to heal wounds.
This is to include:
- Safety evaluation of RPh201 (botanical extract) formulated as an oil solution administered topically three times per week during an overall treatment period of up to 4 weeks in patients with hard to heal wounds.
- Efficacy assessment of wound improvement following the use of RPh201 oil solution (botanical extract) administered topically three times per week during an overall treatment period of up to 4 weeks and at the follow-up visit at 3 months after end of treatment in patients with hard to heal wounds
- Conditions
- Chronic Wound
- Being tested
- RPh201, botanical drug product
- Keywords
- chronic wound, ulcerated wound, venous insufficiency, lymphatic insufficiency, neuropathic wound, diabetic ulcer, post- operative, post-traumatic chronic wound
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPh201, botanical drug productDrug
topical, three times per week for a period of 4 consecutive weeks, followed by a single follow up visit 3 months post end of the last treatment day
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: RPh201, botanical drug product |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety use of RPh201 administered topically three times a week during an overall treatment period of up to 4 weeks, with 52 days follow-up
- Safety evaluation - To demonstrate safety using the RPh201 oil solution in terms of skin irritation score to be less than 2 for erythema /edema individual subject's results or less then 1.9 for Primary Irritation Index (PII) category (see section 6.5.2 and APPENDIX 2) .
- Safety evaluation - To demonstrate safety of using RPh201 oil solution in terms of type and severity of adverse events.
Measured: 90 days
Secondary outcomes (1)
To obtain preliminary data on the efficacy of RPh201 on improving wound status in patients with hard to heal chronic ulcerated wounds
- Evaluation of the correlation between the treatment period and changes in wound area size.
- Assessment of wound closure state in terms of % Non-viable area, % granulation tissue appearance,
- Assessment of wound closure state in terms of time to wound closure.
- Assessment of pain based on a pain analog scale of 1-10.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Due to slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic WoundStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regenera Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TransCom Global Ltd. (CRO)
- Responsible party
- Sponsor
- Investigators
- Eran Tamir, Dr., Principal investigator, High Risk Foot Clinic - Maccabi Health Services Tel Aviv
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429519
- Sponsor's protocol ID
- RGN-WH-001
- Status last verified
- Aug 2018
- First submitted
- 4 Sep 2011
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PRELIMINARY OPEN CLINICAL STUDY, TO ASSESS THE SAFETY AND EFFICACY OF RPh201 APPLIED TOPICALLY FOR THE TREATMENT OF HARD TO HEAL CHRONIC ULCERATED WOUNDS
- ClinicalTrials.gov ID
- NCT01429519
- Acronym / sponsor ID
- RGN-WH-001
- Conditions
- Chronic Wound
- Keywords
- chronic wound, ulcerated wound, venous insufficiency, lymphatic insufficiency, neuropathic wound, diabetic ulcer, post- operative, post-traumatic chronic wound
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to slow recruitment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Regenera Pharma LtdIndustry (pharma, biotech, devices)
- Collaborators
- TransCom Global Ltd. (CRO)
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 7 Sep 2011 (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 study objectives are to evaluate safety and efficacy of topical administration of RPh201 oil solution (botanical extract) for treatment of patients with hard to heal chronic ulcerated wounds.
Detailed description
The study objectives are to evaluate safety and efficacy, of topical administration of RPh201 for treatment of patients with hard to heal wounds.
This is to include:
- Safety evaluation of RPh201 (botanical extract) formulated as an oil solution administered topically three times per week during an overall treatment period of up to 4 weeks in patients with hard to heal wounds.
- Efficacy assessment of wound improvement following the use of RPh201 oil solution (botanical extract) administered topically three times per week during an overall treatment period of up to 4 weeks and at the follow-up visit at 3 months after end of treatment in patients with hard to heal wounds
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: RPh201, botanical drug product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants, either men or women are ≥ 18 years of age.
- Patients must have at least one hard to heal wound of different etiologies (venous insufficiency, lymphatic insufficiency, neuropathic wounds or diabetic ulcers, post- operative and post-traumatic chronic wounds) located on the leg shin or foot.
- The wound is refractive to healing at least 4 weeks prior to treatment, although treated by routine practice.
- Wound area size is in the range of: 3 - 36 square centimeters.
- Patients defined as grade C or above on the granulometer scale (see section 6.5.1).
Key exclusion criteria (12 listed)
- Clinically significant arterial vascular disease with ABI index <0.45 if the peripheral pulse is not palpable, or flatted PVR in case of non palpable arteries.
- Clinical evidence for presence of infection in the soft tissue, joint and/or bone (osteomyelitis).
- Wound has Non-viable tissue which covers more than 50% of the wound area.
- Patients with skin disorders unrelated to the ulcer that are presented adjacent to the wound.
- The wound penetrates into deep organs and involves bone, tendon or joint
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 |
|---|---|---|
| RPh201, botanical drug producttopical, three times per week for a period of 4 consecutive weeks, followed by a single follow up visit 3 months post end of the last treatment day | Drug | Treatment |
Primary outcome
To determine the safety use of RPh201 administered topically three times a week during an overall treatment period of up to 4 weeks, with 52 days follow-up
Time frame: 90 days
* Safety evaluation - To demonstrate safety using the RPh201 oil solution in terms of skin irritation score to be less than 2 for erythema /edema individual subject's results or less then 1.9 for Primary Irritation Index (PII) category (see section 6.5.2 and APPENDIX 2) . * Safety evaluation - To demonstrate safety of using RPh201 oil solution in terms of type and severity of adverse events.
1 secondary outcome
To obtain preliminary data on the efficacy of RPh201 on improving wound status in patients with hard to heal chronic ulcerated wounds
Time frame: 90 days
Results and safety
The study was stopped early (reason given: Due to slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
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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.
Eran Tamir, Dr. principal investigator
High Risk Foot Clinic - Maccabi Health Services Tel Aviv
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RPh201, botanical drug product in people with Chronic Wound, run by Regenera Pharma Ltd at 1 site 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 7 inclusion and 12 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: stopped early, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Due to slow recruitment). Results are not available in the source record.
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?
To determine the safety use of RPh201 administered topically three times a week during an overall treatment period of up to 4 weeks, with 52 days follow-up (time frame: 90 days). 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 4 Sep 2018.