Efficacy of RPh201 Applied Topically for the Treatment of Hard to Heal Chronic Ulcerated Wounds

August 30, 2018 updated by: Regenera Pharma Ltd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel-Aviv, Israel
        • High Risk Foot Clinic - Maccabi Health Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Participants, either men or women are ≥ 18 years of age.
  2. 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.
  3. The wound is refractive to healing at least 4 weeks prior to treatment, although treated by routine practice.
  4. Wound area size is in the range of: 3 - 36 square centimeters.
  5. Patients defined as grade C or above on the granulometer scale (see section 6.5.1).
  6. Participants understand the nature of the procedure and provide written informed consent prior to any study procedure.
  7. Women of child bearing potential must use adequate birth-control precautions.

Exclusion Criteria:

  1. 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.
  2. Clinical evidence for presence of infection in the soft tissue, joint and/or bone (osteomyelitis).
  3. Wound has Non-viable tissue which covers more than 50% of the wound area.
  4. Patients with skin disorders unrelated to the ulcer that are presented adjacent to the wound.
  5. The wound penetrates into deep organs and involves bone, tendon or joint
  6. Wound with sinus tracts
  7. 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.
  8. Treatment with a dressing containing growth factors or other biological dressings within 15 days, prior to the screening visit.
  9. Patients that have a history of alcohol or drug abuse within the last two years.
  10. Female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception.
  11. Participation in another clinical trial within 30 days prior to the Screening Visit or during this study.
  12. Clinically significant and/or uncontrolled condition or other significant medical disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Treatment
Drug: RPh201, botanical drug product
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
  • 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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regenera Pharma Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
TransCom Global Ltd. (CRO)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eran Tamir, Dr., High Risk Foot Clinic - Maccabi Health Services Tel Aviv

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RGN-WH-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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