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

NCT ID: NCT03723603

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-09
• Study Completion Date: 2019-07-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fibrillar Collagen Powder Dressing

Group Type: EXPERIMENTAL

Fibrillar collagen powder dressing

Intervention Type: 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.

Interventions

Fibrillar collagen powder dressing

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medline Industries

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Windy Cole

Role: PRINCIPAL_INVESTIGATOR

Cleveland Foot and Ankle Clinic

Locations

Cleveland Foot and Ankle Clinic

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MED-2018-DIV71-018

Identifier Type: -

Identifier Source: org_study_id