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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-15

Study Completion Date

2019-05-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Wound

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

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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

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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