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

A Case Series Evaluating a Fibrillar Collagen Powder Dressing to Treat Chronic, Stalled Lower-extremity Wounds

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.

Study Overview

• Status: Terminated
• Conditions: Wound
• Intervention / Treatment: Device: Fibrillar collagen powder dressing

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44103
      • Cleveland Foot and Ankle Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fibrillar Collagen Powder Dressing	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Wound Size Over Twelve Week Period	Baseline to 84 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bates-Jensen Wound Assessment Tool	The Bates-Jensen Wound Assessment tool score will be used to assess the wound's status throughout the study. The Bates-Jensen Wound Assessment tool measures wound status. The wound size score ranges from 0 to 5. The wound depth score ranges from 0 to 5. The wound edge score ranges from 0 to 5. The wound undermining score ranges from 0 to 5. The necrotic tissue type score ranges from 1 to 5. The necrotic tissue amount ranges from 1 to 5. The exudate type score ranges from 1 to 5. The exudate amount score ranges from 1 to 5. The skin color surrounding wound score ranges from 1 to 5. The peripheral tissue edema score ranges from 1 to 5. The peripheral tissue induration score score ranges from 1 to 5. The granulation tissue score ranges from 1 to 5. The epithelialization score ranges from 1 to 5. The total score from these sub-scores added together is used as the total BWAT score. For all sub-score values, a value of 0 or 1 is a better outcome.	Baseline to 84 days
Change in Reported Pain Level	The pain score will be recorded with a verbal numeric pain rating scale from 0-10.	Baseline to 84 days

Collaborators and Investigators

• Sponsor: Medline Industries
• Investigators: Principal Investigator: Windy Cole, Cleveland Foot and Ankle Clinic

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 9, 2018
• Primary Completion (ACTUAL): June 4, 2019
• Study Completion (ACTUAL): July 30, 2019

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: October 26, 2018
• First Posted (ACTUAL): October 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: MED-2018-DIV71-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No