WoundsNCT04745806
Post Marketing Trial for Evaluating the Effectiveness of ActiGraft in Treating Lower Extremity Hard To Heal Wounds
A study testing ActiGraft in people with Wounds, run by RedDress Ltd. at 1 site in Israel.
Trial summary
The study is a prospective, single arm, post- marketing study. The subjects enrolled to the study will receive weekly applications of ActiGraft until complete healing or until investigator's decision that patient can no longer benefit from the study treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds
- What is being tested?
- ActiGraft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2021to 1 Jan 2023
- 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
- Subject is ≥18 years of age
- Patient with a chronic lower extremity ulcer (i.e DFU, VLU, …)
- Ulcer duration >30 days.
- Ulcer size decreased in less than 30% in the 14 days prior to enrollment, while treated with standard of care (or advanced treatment)
- Subject must be willing to comply with the protocol including having blood drawn to create the ActiGraft
- Subject can read and understand the Informed Consent form
Who cannot join
- Presence of active underlying osteomyelitis.
- Known malignancy in the reference wound bed or margins of the wound
- Cannot withdraw blood in the required amount technically.
- Subject is receiving (i.e., within the past 30 days) systemic steroids (more than 10mg per day)
- Subject has been treated with wound dressings that include growth factors, engineered tissues or skin substitutes (within the past 30 days).
- Subject has been treated with hyperbaric oxygen, wound VAC or Ozone gas(O3) within the past 5 days or is scheduled to receive during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single Arm, Post Marketing Study for Evaluating the Effectiveness of ActiGraft in Treating Lower Extremity Hard to Heal Wounds
The study is a prospective, single arm, post- marketing study. The subjects enrolled to the study will receive weekly applications of ActiGraft until complete healing or until investigator's decision that patient can no longer benefit from the study treatment.
- Conditions
- Wounds
- Being tested
- ActiGraft
- Keywords
- Chronic, Ulcer, Lower extremity, DFU, VLU
- Medical subject headings
- Wounds and Injuries, Bronchiolitis Obliterans Syndrome, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiGraftDevice
Whole blood clot (WBC) gel
| Study group | Role | What they receive |
|---|---|---|
| ActiGraft | Experimental | Whole blood clot (WBC) gel Receives: Device: ActiGraft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Reduction in Wound Size Over 12 Weeks
The change in wound area (decrease or increase) with respect to the area at baseline, expressed as a percentage.
Measured: 4, 8, and 12 weeks
Secondary outcomes (4)
Number of Participants Achieving a Complete Wound Closure at 12 Weeks
Skin re-epithelialization without drainage or dressing requirements.
Measured: 12 weeks
Number of Participants Achieving a Complete re-epithelialization at 18 and 24 Weeks
Skin re-epithelialization without drainage or dressing requirements.
Measured: 18 and 24 weeks
Percent of Reduction in Wound Size Over 18 and 24 Weeks.
The change in wound area (decrease or increase) with respect to the area at baseline, expressed as a percentage for wound treated beyond 12 weeks, per the investigator's decision
Measured: 18 and 24 weeks
The change in wound pain by 12 weeks
Pain assessment would be done by using the Numeric Rating Scale (NRS). Subject chooses a number on a 1 to 10 scale that best describes his ulcer pain, while 0 represents "No Pain" and 10- " Worst Pain Imaginable "test, a scale between .
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 posted9 Feb 2021
- Study start1 Mar 2021
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- RedDress Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharon Sirota, Study director, RedDress Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745806
- Sponsor's protocol ID
- RD007
- Status last verified
- Nov 2024
- First submitted
- 4 Feb 2021
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results will be part of several scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm, Post Marketing Study for Evaluating the Effectiveness of ActiGraft in Treating Lower Extremity Hard to Heal Wounds
- ClinicalTrials.gov ID
- NCT04745806
- Acronym / sponsor ID
- RD007
- Conditions
- Wounds
- Keywords
- Chronic, Ulcer, Lower extremity, DFU, VLU
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- RedDress Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 9 Feb 2021 (actual)
- 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 is a prospective, single arm, post- marketing study. The subjects enrolled to the study will receive weekly applications of ActiGraft until complete healing or until investigator's decision that patient can no longer benefit from the study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ActiGraft | Experimental | Device: ActiGraftWhole blood clot (WBC) gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is ≥18 years of age
- Patient with a chronic lower extremity ulcer (i.e DFU, VLU, …)
- Ulcer duration >30 days.
- Ulcer size decreased in less than 30% in the 14 days prior to enrollment, while treated with standard of care (or advanced treatment)
- Subject must be willing to comply with the protocol including having blood drawn to create the ActiGraft
Key exclusion criteria (6 listed)
- Presence of active underlying osteomyelitis.
- Known malignancy in the reference wound bed or margins of the wound
- Cannot withdraw blood in the required amount technically.
- Subject is receiving (i.e., within the past 30 days) systemic steroids (more than 10mg per day)
- Subject has been treated with wound dressings that include growth factors, engineered tissues or skin substitutes (within the past 30 days).
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 |
|---|---|---|
| ActiGraftWhole blood clot (WBC) gel | Device | ActiGraft |
Primary outcome
Percent of Reduction in Wound Size Over 12 Weeks
Time frame: 4, 8, and 12 weeks
The change in wound area (decrease or increase) with respect to the area at baseline, expressed as a percentage.
4 secondary outcomes
Number of Participants Achieving a Complete Wound Closure at 12 Weeks
Time frame: 12 weeks
Number of Participants Achieving a Complete re-epithelialization at 18 and 24 Weeks
Time frame: 18 and 24 weeks
Percent of Reduction in Wound Size Over 18 and 24 Weeks.
Time frame: 18 and 24 weeks
The change in wound pain by 12 weeks
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: Yes. The results will be part of several scientific publications.
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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.
Sharon Sirota study director
RedDress Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActiGraft in people with Wounds, run by RedDress 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 6 inclusion and 6 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 15 Nov 2024. 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.
Are results available for this study?
The study was stopped early (reason given: low enrollment). 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?
Percent of Reduction in Wound Size Over 12 Weeks (time frame: 4, 8, and 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 15 Nov 2024.