Safety and Efficacy of ActiGraft Treatment in Wound Care in Medical Centers

NCT ID: NCT04699305

Last Updated: 2025-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-14

Study Completion Date

2027-01-31

Brief Summary

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Multicenter observational study to explore the efficacy of ActiGraft in the treatment of exuding cutaneous wounds in real-life usage.

Detailed Description

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Conditions

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Cutaneous Wounds

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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ActiGraft

Whole blood clot (WBC) gel

ActiGraft

Intervention Type DEVICE

Whole blood clot (WBC) gel

Interventions

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ActiGraft

Whole blood clot (WBC) gel

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Subject/LAR is unable to read and understand English or Spanish.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RedDress Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sharon Sirota

Role: STUDY_DIRECTOR

RedDress Ltd.

Locations

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Wound Care Experts

Las Vegas, Nevada, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sharon Sirota

Role: CONTACT

+972545800765

Facility Contacts

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Naz Wahab, M.D

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35881826 (View on PubMed)

Other Identifiers

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RD005

Identifier Type: -

Identifier Source: org_study_id

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