Cutaneous WoundsNCT04699305
Safety and Efficacy of ActiGraft Treatment in Wound Care in Medical Centers
An observational study of Cutaneous Wounds, run by RedDress Ltd. at 1 site in United States.
Trial summary
Multicenter observational study to explore the efficacy of ActiGraft in the treatment of exuding cutaneous wounds in real-life usage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Wounds
- What is being tested?
- ActiGraft
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2019to 31 Jan 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Patients with all types of exuding cutaneous wound
Who may be able to join
- Subject is ≥18 years of age
- Subject has an exuding cutaneous wound
- Subject agrees to the use of his health data, including photos of his wound in analysis and publications
- Subject/LAR must be able to read and understand English and/or Spanish
Who cannot join
- Subject/LAR is unable to read and understand English or Spanish.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wound Care Experts
Las Vegas, Nevada, 89128
Naz Wahab, M.D
About this study
Official title: An Observational Clinical Registry to Collect Safety and Efficacy Data on Wound Care in Medical Centers
Multicenter observational study to explore the efficacy of ActiGraft in the treatment of exuding cutaneous wounds in real-life usage.
- Conditions
- Cutaneous Wounds
- Being tested
- ActiGraft
- Keywords
- DFU, PU, Surgical, Vascular, Trauma
- Medical subject headings
- Wounds and Injuries
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 | 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.
Percentage area reduction (PAR) at 4 weeks
Change from baseline at 4 weeks of wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT).
Measured: 4 weeks
Nature, frequency, and severity of adverse events in the intent to treat population
Nature, frequency, and severity (by CTCAE5) of adverse events
Measured: 1 year
Secondary outcomes (1)
Percentage area reduction at 8 and 12 weeks
Change from baseline at 8 and 12 weeks of wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT).
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 posted7 Jan 2021
- Study start14 Feb 2019
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cutaneous 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Year
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
- NCT04699305
- Sponsor's protocol ID
- RD005
- Status last verified
- Jul 2025
- First submitted
- 5 Jan 2021
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The results will be part of several scientific publications
Publications
Williams M, Davidson D, Wahab N, Hawkins J, Wachuku CD, Snyder R. Innovative treatment utilizing an autologous blood clot for diabetic foot ulcers. Wounds. 2022 Jul;34(7):195-200. doi: 10.25270/wnds/21089.
PubMed 35881826
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Clinical Registry to Collect Safety and Efficacy Data on Wound Care in Medical Centers
- ClinicalTrials.gov ID
- NCT04699305
- Acronym / sponsor ID
- RD005
- Conditions
- Cutaneous Wounds
- Keywords
- DFU, PU, Surgical, Vascular, Trauma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- RedDress Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 7 Jan 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.
Multicenter observational study to explore the efficacy of ActiGraft in the treatment of exuding cutaneous wounds in real-life usage.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ActiGraft | – | Device: ActiGraftWhole blood clot (WBC) gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with all types of exuding cutaneous wound
Key inclusion criteria (4 listed)
- Subject is ≥18 years of age
- Subject has an exuding cutaneous wound
- Subject agrees to the use of his health data, including photos of his wound in analysis and publications
- Subject/LAR must be able to read and understand English and/or Spanish
Key exclusion criteria (1 listed)
- Subject/LAR is unable to read and understand English or Spanish.
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
Percentage area reduction (PAR) at 4 weeks
Time frame: 4 weeks
Change from baseline at 4 weeks of wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT).
Nature, frequency, and severity of adverse events in the intent to treat population
Time frame: 1 year
Nature, frequency, and severity (by CTCAE5) of adverse events
1 secondary outcome
Percentage area reduction at 8 and 12 weeks
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Derived from this study: PubMed 35881826Williams M, Davidson D, Wahab N, Hawkins J, Wachuku CD, Snyder R. Innovative treatment utilizing an autologous blood clot for diabetic foot ulcers. Wounds. 2022 Jul;34(7):195-200. doi: 10.25270/wnds/21089.
- 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.
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?
An observational study of Cutaneous Wounds, run by RedDress Ltd. at 1 site in United States.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 29 Jul 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharon Sirota (+972545800765, sharon@reddress.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage area reduction (PAR) at 4 weeks (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04699305, which also lists 1 linked publication.
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 29 Jul 2025.