- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03909503
A Case Series Evaluating a Collagen Wound Dressing to Treat Wounds
October 13, 2021 updated by: Medline Industries
A Case Series Evaluating a Porcine-derived Collagen Wound Dressing to Treat Chronic Lower Extremity Wounds
Chronic wounds are a source of significant morbidity and escalated healthcare costs.
The wound care professional has a myriad of modern wound dressings to choose from, each of which has benefits and drawbacks.
An understanding of how a given dressing performs in healing a particular wound is crucial in order to determine a clinical mapping of wound dressings to wound types; such a categorization would lead to more efficient clinical decision making and better patient outcomes.
This case series will evaluate the ability of a porcine-derived collagen dressing to improve healing of chronic lower-extremity wounds.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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 at least one of the following types of wounds below the knee: diabetic ulcer, pressure ulcer, venous ulcer, ulcer of mixed-vascular origin, traumatic wound, post-surgical wound
- Wound has been present for at least four weeks
- Wound is free of necrotic tissue or it is possible for necrotic tissue to be removed by typical debridement practices prior to or during treatment phase
- Wound has not healed after using at least one other type of advanced wound care treatment
- Wound size is between 1 and 100 cm2
- 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 free of infection and absence of osteomyelitis.
Exclusion Criteria:
- Pregnant, planning to become pregnant during the study timeframe, or breast feeding
- Has a known allergy to porcine products
- Has an allergy or sensitivity to any type of collagen
- Unable or unwilling to receive porcine collagen
- Wound is infected or there is presence of osteomyelitis
- 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Porcine-derived collagen wound dressing
The dressing is a sheet of collagen composed of type I collagen derived from porcine peritoneal membrane.
The dressing also contains additional components from the procine extracellular matrix.
The dressing is a currently marketed, cleared device in the United States indicated for the management of full- and partial-thickness wounds, including: pressure ulcers, diabetic ulcers, venous ulcers, and several other wound types.
|
Patients who meet the inclusion criteria will be treated with porcine-derived collagen dressings.
The dressing will be used in accordance with its label.
After cleansing the wound, the dressing will be placed on the wound.
Appropriate primary and secondary dressings will be placed over the intervention product.
Patients will visit the clinic once per week to have their dressings re-applied.
Wound evaluations will take place once per week with the intervention lasting up to twelve weeks.
Concomitant standard of care such as compression for venous ulcers will be provided according to individual patient needs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in wound size over a twelve week period
Time Frame: Baseline to 84 days
|
Baseline to 84 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bates-Jensen Wound Assessment Tool score
Time Frame: Baseline to 84 days
|
The Bates-Jensen Wound Assessment tool score will be used to assess the wound's status throughout the study.
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.
A score of 1 indicates the healthiest and 5 indicates the unhealthiest attribute for each characteristic.
|
Baseline to 84 days
|
Change in reported pain level: verbal numeric pain rating scale
Time Frame: Baseline to 84 days
|
The pain will be recorded using a verbal numeric pain rating scale from 0 to 10.
A score of 0 indicates no pain and a score of 10 indicates the highest rated pain.
|
Baseline to 84 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
September 1, 2021
Primary Completion (ANTICIPATED)
December 1, 2021
Study Completion (ANTICIPATED)
February 1, 2022
Study Registration Dates
First Submitted
April 8, 2019
First Submitted That Met QC Criteria
April 9, 2019
First Posted (ACTUAL)
April 10, 2019
Study Record Updates
Last Update Posted (ACTUAL)
October 20, 2021
Last Update Submitted That Met QC Criteria
October 13, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MED-2018-DIV71-029
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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