Back to resultsAn Evaluation of a Fibrillar Collagen Dressing to Treat Chronic, Stalled Lower-extremity Wounds
Primary Purpose
Wound
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fibrillar collagen powder dressing
Sponsored by
About this trial
This is an interventional treatment trial for Wound
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
Sites / Locations
- Valley Foot and Ankle Specialty Providers
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fibrillar Collagen Powder Dressing
Arm Description
Outcomes
Primary Outcome Measures
Change in wound size over twelve week period
Secondary Outcome Measures
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.
Change in reported pain level
The pain score will be recorded with a verbal numeric pain rating scale from 0-10.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03723577
Brief Title
An Evaluation of a Fibrillar Collagen Dressing to Treat Chronic, Stalled Lower-extremity Wounds
Official Title
A Case Series Evaluating a Fibrillar Collagen Powder Dressing to Treat Chronic, Stalled Lower-extremity Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
No subjects enrolled at site.
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
May 14, 2019 (Actual)
Study Completion Date
May 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medline Industries
4. Oversight
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.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fibrillar Collagen Powder Dressing
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Fibrillar collagen powder dressing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in wound size over twelve week period
Time Frame
Baseline to 84 days
Secondary Outcome Measure Information:
Title
Change in Bates-Jensen Wound Assessment Tool
Description
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.
Time Frame
Baseline to 84 days
Title
Change in reported pain level
Description
The pain score will be recorded with a verbal numeric pain rating scale from 0-10.
Time Frame
Baseline to 84 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmy Oji, DPM
Organizational Affiliation
Valley Foot and Ankle Specialty Providers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Valley Foot and Ankle Specialty Providers
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Evaluation of a Fibrillar Collagen Dressing to Treat Chronic, Stalled Lower-extremity Wounds
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