Foot Ulcer, DiabeticHEALEDNCT01729286
Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix
A study testing PriMatrix Moist Wound Therapy in people with Foot Ulcer, Diabetic, run by Integra LifeSciences Corporation at 18 sites in 2 countries.
Trial summary
The objective of this study is to compare the effectiveness of PriMatrix Moist Wound Therapy (MWT) with Standard of Care MWT for the treatment of chronic diabetic foot ulcers in subjects with diabetes mellitus and without significantly compromised arterial circulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Ulcer, Diabetic
- What is being tested?
- PriMatrix Moist Wound Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Sep 2012to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type I or Type II diabetes
- A diabetic foot ulcer located on the foot or ankle at least one square centimeter
Who cannot join
- Suspected or confirmed signs/symptoms of wound infection
- Hypersensitivity to bovine collagen
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States15 sites
Joseph M. Still Research Foundation
Augusta, Georgia, 30909
American Health Network
Carmel, Indiana, 46032
Imperial Health
Lake Charles, Louisiana, 70601
North Shore Long Island Jewish Comprehensive Wound Healing Center
Lake Success, New York, 11042
Fairfield Medical Center
Lancaster, Ohio, 43130
University of Southern California
Los Angeles, California, 90033
Foot and Ankle Clinic
Los Angeles, California, 90057
University of Tennessee
Memphis, Tennessee, 38103
Advanced Research Institute of Miami
Miami, Florida, 33030
Foot & Andle Center of Mooresville
Mooresville, Indiana, 46158
Kansas City Vascular
North Kansas City, Missouri, 64116
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
St. Anthony's Medical Center
St Louis, Missouri, 63128
Advanced Foot & Ankle Specialists
Tampa, Florida, 33606
Wake Forest University
Winston-Salem, North Carolina, 27157
Puerto Rico3 sites
Centro Podiatrico del Norte
Arecibo, 00612
Renier Gonzalez-Cruz
Juana Diaz, 00795
VA Carribean Healthcare System
San Juan, 00921
About this study
Official title: A Multi-Center, Prospective, Randomized Study With PriMatrix Dermal Repair Scaffold Moist Wound Therapy and Standard of Care Moist Wound Therapy for the Treatment of Chronic Diabetic Foot Ulcers
The objective of this study is to compare the effectiveness of PriMatrix Moist Wound Therapy (MWT) with Standard of Care MWT for the treatment of chronic diabetic foot ulcers in subjects with diabetes mellitus and without significantly compromised arterial circulation.
Read the detailed description
This study will be a multi-center, prospective, randomized single-blinded study evaluating the efficacy of PriMatrix MWT versus Standard of Care MWT in achieving complete wound closure of chronic diabetic foot ulcers by 12 weeks (84 days). To measure wound recidivism and changes in functional quality of life, each subject will complete the Cardiff Wound Impact Schedule and the SF-36v2™ at three time points during the study i) at initial screening, ii) at completion of treatment phase, and iii)at 24 weeks (post-randomization). Additionally, the data obtained from the SF-36v2™ will be used in an economic evaluation of the treatment arms.
- Conditions
- Foot Ulcer, Diabetic
- Being tested
- PriMatrix Moist Wound Therapy, Standard of Care Moist Wound Therapy
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PriMatrix Moist Wound TherapyDevice
Also called PriMatrix Dermal Repair Scaffold
sharp debridement, PriMatrix, a dressing regimen that maintains a moist wound healing environment, and offloading
Standard of Care Moist Wound TherapyOther
sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading
| Study group | Role | What they receive |
|---|---|---|
| PriMatrix Moist Wound Therapy | Active comparator | sharp debridement, Primatrix, a dressing regimen that maintains a moist wound healing environment, and offloading Receives: Device: PriMatrix Moist Wound Therapy; Other: Standard of Care Moist Wound Therapy |
| Standard of Care Moist Wound Therapy | Other | sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading Receives: Other: Standard of Care Moist Wound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete wound closure
Measured: by 12 weeks
Secondary outcomes (3)
Change in predicted medical expenditures between PriMatrix and Standard of Care
Measured: over 24 weeks
Change in quality of life measurements between PriMatrix and Standard of Care
Measured: between baseline and 24 weeks
Nonserious and serious adverse events
Measured: over 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Ulcer, DiabeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Starinski, DPM, Study chair, TEI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729286
- Sponsor's protocol ID
- TEI-007
- Acronym
- HEALED
- Status last verified
- Oct 2016
- First submitted
- 13 Nov 2012
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective, Randomized Study With PriMatrix Dermal Repair Scaffold Moist Wound Therapy and Standard of Care Moist Wound Therapy for the Treatment of Chronic Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT01729286
- Acronym / sponsor ID
- HEALED / TEI-007
- Conditions
- Foot Ulcer, Diabetic
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 20 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare the effectiveness of PriMatrix Moist Wound Therapy (MWT) with Standard of Care MWT for the treatment of chronic diabetic foot ulcers in subjects with diabetes mellitus and without significantly compromised arterial circulation.
Detailed description
This study will be a multi-center, prospective, randomized single-blinded study evaluating the efficacy of PriMatrix MWT versus Standard of Care MWT in achieving complete wound closure of chronic diabetic foot ulcers by 12 weeks (84 days). To measure wound recidivism and changes in functional quality of life, each subject will complete the Cardiff Wound Impact Schedule and the SF-36v2™ at three time points during the study i) at initial screening, ii) at completion of treatment phase, and iii)at 24 weeks (post-randomization). Additionally, the data obtained from the SF-36v2™ will be used in an economic evaluation of the treatment arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PriMatrix Moist Wound Therapy | Active comparator | Device: PriMatrix Moist Wound Therapy, Other: Standard of Care Moist Wound Therapysharp debridement, Primatrix, a dressing regimen that maintains a moist wound healing environment, and offloading |
| Standard of Care Moist Wound Therapy | Other | Other: Standard of Care Moist Wound Therapysharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type I or Type II diabetes
- A diabetic foot ulcer located on the foot or ankle at least one square centimeter
Key exclusion criteria (2 listed)
- Suspected or confirmed signs/symptoms of wound infection
- Hypersensitivity to bovine collagen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PriMatrix Moist Wound TherapyAlso: PriMatrix Dermal Repair Scaffoldsharp debridement, PriMatrix, a dressing regimen that maintains a moist wound healing environment, and offloading | Device | PriMatrix Moist Wound Therapy |
| Standard of Care Moist Wound Therapysharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading | Other | PriMatrix Moist Wound Therapy, Standard of Care Moist Wound Therapy |
Primary outcome
Complete wound closure
Time frame: by 12 weeks
3 secondary outcomes
Change in predicted medical expenditures between PriMatrix and Standard of Care
Time frame: over 24 weeks
Change in quality of life measurements between PriMatrix and Standard of Care
Time frame: between baseline and 24 weeks
Nonserious and serious adverse events
Time frame: over 24 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Individual participant dataSharing planned: No
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Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Starinski, DPM study chair
TEI
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PriMatrix Moist Wound Therapy in people with Foot Ulcer, Diabetic, run by Integra LifeSciences Corporation at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete wound closure (time frame: by 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.