NCT04699305

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Feb 2019Jan 2027

Study Start

First participant enrolled

February 14, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

7.4 years

First QC Date

January 5, 2021

Last Update Submit

July 28, 2025

Conditions

Cutaneous Wounds

Keywords

DFU, PU, Surgical, Vascular, Trauma

Outcome Measures

Primary Outcomes (2)

  • Percentage area reduction (PAR) at 4 weeks

    Change from baseline at 4 weeks of wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT).

    4 weeks

  • Nature, frequency, and severity of adverse events in the intent to treat population

    Nature, frequency, and severity (by CTCAE5) of adverse events

    1 year

Secondary Outcomes (1)

  • Percentage area reduction at 8 and 12 weeks

    12 weeks

Other Outcomes (1)

  • Reduction in pain at 4 weeks

    4 weeks

Study Arms (1)

ActiGraft

Whole blood clot (WBC) gel

Device: ActiGraft

Interventions

ActiGraftDEVICE

Whole blood clot (WBC) gel

ActiGraft

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with all types of exuding cutaneous wound

You may qualify if:

  • 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

You may not qualify if:

  • Subject/LAR is unable to read and understand English or Spanish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wound Care Experts

Las Vegas, Nevada, 89128, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35881826DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Sharon Sirota

    RedDress Ltd.

    STUDY DIRECTOR

Central Study Contacts

Sharon Sirota

CONTACT

+972545800765sharon@reddress.co.il

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 7, 2021

Study Start

February 14, 2019

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

July 29, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

The results will be part of several scientific publications

Shared Documents
STUDY PROTOCOL
Time Frame
Upon publication

Locations

US(1)