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A Prospective, Open Label, Multicenter Trial for Evaluating the Efficacy of Treating and Managing Wounds in Elderly Population in Specialized Nursing Facilities Using RD1

NCT04577183 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-12-02

Study results available
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Summary

The study is a prospective, single arm, multicenter efficacy study, consisting of 60 subjects who will complete the study (note: if any patients are lost to follow-up or withdrawn, enrollment will increase to compensate for loss of these subjects). The subjects will receive up to 16 RD1 applications. In case of complete healing, subject will be called for one confirmatory visit two weeks later or before discharge from the SNF (the earlier of the two). Subject data will be kept in each site's records.

All diabetic subjects' glycemic management will be performed by a qualified physician. All subjects will have wound care specialist or wound surgeon or dermatologist involved in their wound care

Conditions

  • Diabetic Foot Ulcer
  • Pressure Ulcer
  • Venous Leg Ulcer
  • Trauma Injury
  • Skin Tear
  • Chronic Ulcer

Interventions

DEVICE

RD1 System

The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings.

Sponsors & Collaborators

  • RedDress Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-11
Primary Completion
2019-02-01
Completion
2019-02-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04577183 on ClinicalTrials.gov