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Recruiting NCT04699305

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

Observational Cutaneous Wounds

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ActiGraft.
Who it may be relevant to
Registry conditions: Cutaneous Wounds. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

An Observational Clinical Registry to Collect Safety and Efficacy Data on Wound Care in Medical Centers

Overview

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

Interventions

  • Device ActiGraft
    Whole blood clot (WBC) gel

Primary outcome measures

  • Percentage area reduction (PAR) at 4 weeks [Time frame: 4 weeks]
  • Nature, frequency, and severity of adverse events in the intent to treat population [Time frame: 1 year]
Secondary outcome measures (1)
  • Percentage area reduction at 8 and 12 weeks [Time frame: 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

United States · 1 center
  • Wound Care Experts — Las Vegas

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. PMID 35881826

Identifiers

NCT: NCT04699305 · RD005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗