An Evaluation of a Collagen Dressing to Treat Chronic, Stalled Lower-extremity Wounds

NCT03723603 | Terminated Results FDA Device

• 1 other identifier: MED-2018-DIV71-018
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who meet the inclusion criteria will be provided with fibrillar collagen powder dressing. The powder dressing will be used in accordance with its label. After cleansing the wound by the clinical site staff, the powder is placed directly on the wound, and then the wound will be covered with an appropriate moisture retentive secondary dressing. Patients will visit the clinic twice a week to have the powder re-applied. Wound evaluations will take place once a week at the outpatient clinic, with the intervention lasting up to twelve weeks. Concurrent standard of care, such as compression for venous ulcers, will be provided.

Conditions

Wound

Outcome Measures

Primary Outcomes (1)

• Change in Wound Size Over Twelve Week Period

  Baseline to 84 days

Secondary Outcomes (2)

• Change in Bates-Jensen Wound Assessment Tool

  Baseline to 84 days

• Change in Reported Pain Level

  Baseline to 84 days

Study Arms (1)

Fibrillar Collagen Powder Dressing

EXPERIMENTAL

Device: Fibrillar collagen powder dressing

Interventions

Fibrillar collagen powder dressing DEVICE

A powder-like fibrillar collagen microsponge composed of Type I porcine dermis collagen. The dressing is a currently marketed, cleared device in the United States, indicated for the management of full and partial thickness wounds: pressure ulcers, diabetic ulcers, caused by mixed vascular origin, venous ulcers, and several other wound types.

Fibrillar Collagen Powder Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has one of the following types of wounds below the knee: diabetic ulcers, pressure ulcers, venous ulcers, ulcers of mixed-vascular origin, traumatic wounds, or post-surgical wounds
• Wound has been present for at least four weeks
• Wound is free of necrotic tissue or debridement practices will take place prior to initial visit in order to remove necrotic tissue
• Wound has failed at least one wound care treatment
• Wound size is between 1 and 100 square centimeters
• Patient has adequate circulation as demonstrated by biphasic or triphasic Doppler waveform, measured within three months prior to study enrollment. If monophasic on exam, then non-invasive tests must display Ankle Brachial Index greater than 0.8 and no worse than mild disease on segmental pressures.
• Wound is confirmed as being free of infection and absence of osteomyelitis

You may not qualify if:

• Pregnant, planning to become pregnant during the study timeframe, or breast feeding
• Unable or unwilling to receive porcine collagen
• Wound is infected or presence of osteomyelitis
• Allergy or sensitivity to collagen
• Inability, in the opinion of the Investigator to follow protocol requirements, attend follow up visits in a timely manner, or otherwise comply with the requirements of the protocol

Sponsors & Collaborators

• Medline Industries: lead

Study Sites (1)

Cleveland Foot and Ankle Clinic

Cleveland, Ohio, 44103, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Results Point of Contact

• Title: Stephanie Martynenko
• Organization: Medline Industries, Inc

smartynenko@medline.com

2242163822

Study Officials

• Windy Cole

  Cleveland Foot and Ankle Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 29, 2018
• Study Start: November 9, 2018
• Primary Completion: June 4, 2019
• Study Completion: July 30, 2019
• Last Updated: March 18, 2020
• Results First Posted: March 18, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)