Post Marketing Trial for Evaluating the Effectiveness of... | NCT04745806

Studies
Post Marketing Trial for Evaluating the Effectiveness of ActiGraft in Treating Lower Extremity Hard To Heal Wounds

NCT04745806

Sponsor

RedDress Ltd.

Status

Terminated

Last Update Posted

Nov 15, 2024Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

Wounds

Interventions

ActiGraft

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

low enrollment

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

Jan 1, 2023Actual

Completion Date

Jan 1, 2023Actual

First Submitted Date

Feb 4, 2021

First Submission Date that Met QC Criteria

Feb 4, 2021

First Posted Date

Feb 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2024

Last Update Posted Date

Nov 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study is a prospective, single arm, post- marketing study. The subjects enrolled to the study will receive weekly applications of ActiGraft until complete healing or until investigator's decision that patient can no longer benefit from the study treatment.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ActiGraft	Experimental	Whole blood clot (WBC) gel	Device: ActiGraft

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ActiGraft	Device	Whole blood clot (WBC) gel	ActiGraft

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent of Reduction in Wound Size Over 12 Weeks	The change in wound area (decrease or increase) with respect to the area at baseline, expressed as a percentage.	4, 8, and 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Achieving a Complete Wound Closure at 12 Weeks	Skin re-epithelialization without drainage or dressing requirements.	12 weeks
Number of Participants Achieving a Complete re-epithelialization at 18 and 24 Weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is ≥18 years of age
Patient with a chronic lower extremity ulcer (i.e DFU, VLU, …)
Ulcer duration >30 days.
Ulcer size decreased in less than 30% in the 14 days prior to enrollment, while treated with standard of care (or advanced treatment)
Subject must be willing to comply with the protocol including having blood drawn to create the ActiGraft
Subject can read and understand the Informed Consent form

Exclusion Criteria:

Presence of active underlying osteomyelitis.
Known malignancy in the reference wound bed or margins of the wound
Cannot withdraw blood in the required amount technically.
Subject is receiving (i.e., within the past 30 days) systemic steroids (more than 10mg per day)
Subject has been treated with wound dressings that include growth factors, engineered tissues or skin substitutes (within the past 30 days).
Subject has been treated with hyperbaric oxygen, wound VAC or Ozone gas(O3) within the past 5 days or is scheduled to receive during the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Sharon Sirota	RedDress Ltd.	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The results will be part of several scientific publications.

Types

Study Protocol

Time Frame

Upon publication.

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries
D000092122	Bronchiolitis Obliterans Syndrome
D014456	Ulcer

Ancestor Terms

ID	Term
D000092124	Organizing Pneumonia
D001989	Bronchiolitis Obliterans
D001988	Bronchiolitis
D001991	Bronchitis

Browse Leaves

Not provided

Browse Branches

Not provided