DiabetesPhase 4NCT01108263
Use of INTEGRA™ Flowable Wound Matrix to Manage Diabetic Foot Ulcers
A Phase 4 study testing INTEGRA™ Flowable Matrix (Collagen) in people with Diabetes and Foot Ulcer, run by Georgetown University at 1 site in United States.
Trial summary
After determining if subjects meet the criteria to be included in the study they will be randomly placed in either Group 1 or 2 and patient will be blinded from randomization group. Subjects will walk across a pressure plate to determine different areas of high pressure under the foot. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Foot Ulcer
- What is being tested?
- INTEGRA™ Flowable Matrix (Collagen)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Aug 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject is 18 years of age or older
- Subjects with a plantar diabetic foot wound, with or without a previous history of partial foot amputation.
- Subject has Diabetes Mellitus (type 1 or type 2).
- University of Texas Classification 1A with a wound area measurement ranging between 0.3-4.0cm².
- Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study.
Who cannot join
- Subjects < 18 years of age
- Subject is non-diabetic
- Subjects who present with wounds of etiology other than diabetes
- Subject demonstrates increased signs of clinical infection
- Has active malignant disease of any kind. A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry.
- University of Texas Classification greater than grade 1A
Show all 9Show fewer
- Diabetic plantar foot wounds measuring >4.0cm²
- Subjects who present with significant vascular or metabolic comorbidity that would preclude wound healing
- Subjects participating in any other trials in regards to the diabetic foot ulcer
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
Official title: The Use of INTEGRA™ Flowable Wound Matrix to Manage Diabetic Foot Ulcers in High Risk Populations: A Prospective, Randomized, Controlled Trial
- After determining if subjects meet the criteria to be included in the study they will be randomly placed in either Group 1 or 2 and patient will be blinded from randomization group.
- Subjects will walk across a pressure plate to determine different areas of high pressure under the foot. This will be done before the INTEGRA application and at every other follow-up visit.
- Both groups will be debrided and have pictures taken in the OR
- Group 1 will have Integra Flowable Wound Matrix applied onto the wound in the OR and Group 2 will have the Integra Flowable Wound Matrix applied onto the wound and injected subcutaneously in the OR.
- Subjects will be placed in a total contact cast at each visit.
If wound healing occurs prior to 12 weeks, a final assessment visit will be done and the status of the healed ulcer will be assessed.
- Conditions
- Diabetes, Foot Ulcer
- Being tested
- INTEGRA™ Flowable Matrix (Collagen)
- Medical subject headings
- Diabetes Mellitus, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTEGRA™ Flowable Matrix (Collagen)Drug
Also called Integra Flowable Wound Matrix
INTEGRA™ Flowable Wound Matrix is an advanced 3-D porous matrix comprised of granulated cross-linked bovine tendon collagen and glycosaminoglycan. It provides a scaffold for cellular invasion and capillary growth. The collagen and glycosaminoglycan mix is hydrated with saline and applied on the wound bed.
| Study group | Role | What they receive |
|---|---|---|
| Integra Flowable on wound bed | Active comparator | INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once. Receives: Drug: INTEGRA™ Flowable Matrix (Collagen) |
| INTEGRA Flowable on wound & injected subcutaneously | Active comparator | INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once. Receives: Drug: INTEGRA™ Flowable Matrix (Collagen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Decrease in Wound Size
Measured: 12 weeks
Secondary outcomes (1)
Decreased Peak Plantar Pressures in Both the Static and Dynamic Phases of Gait as Compared to Pre-operative Pressure Values.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: Sponsor Terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Integra LifeSciences Corporation
- Responsible party
- Principal investigator, John Steinberg, DPM, Georgetown University
- Investigators
- John Steinberg, DPM, Principal investigator, Georgetown University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108263
- Sponsor's protocol ID
- 2010-006
- Status last verified
- Feb 2014
- First submitted
- 20 Apr 2010
- Last updated
- 17 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of INTEGRA™ Flowable Wound Matrix to Manage Diabetic Foot Ulcers in High Risk Populations: A Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01108263
- Acronym / sponsor ID
- 2010-006
- Conditions
- Diabetes, Foot Ulcer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Integra LifeSciences Corporation
- Study start
- Jun 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 21 Apr 2010 (estimated)
- Results
- Posted 17 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- After determining if subjects meet the criteria to be included in the study they will be randomly placed in either Group 1 or 2 and patient will be blinded from randomization group.
- Subjects will walk across a pressure plate to determine different areas of high pressure under the foot. This will be done before the INTEGRA application and at every other follow-up visit.
- Both groups will be debrided and have pictures taken in the OR
- Group 1 will have Integra Flowable Wound Matrix applied onto the wound in the OR and Group 2 will have the Integra Flowable Wound Matrix applied onto the wound and injected subcutaneously in the OR.
- Subjects will be placed in a total contact cast at each visit.
If wound healing occurs prior to 12 weeks, a final assessment visit will be done and the status of the healed ulcer will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integra Flowable on wound bed | Active comparator | Drug: INTEGRA™ Flowable Matrix (Collagen)INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once. |
| INTEGRA Flowable on wound & injected subcutaneously | Active comparator | Drug: INTEGRA™ Flowable Matrix (Collagen)INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is 18 years of age or older
- Subjects with a plantar diabetic foot wound, with or without a previous history of partial foot amputation.
- Subject has Diabetes Mellitus (type 1 or type 2).
- University of Texas Classification 1A with a wound area measurement ranging between 0.3-4.0cm².
- Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study.
Key exclusion criteria (9 listed)
- Subjects < 18 years of age
- Subject is non-diabetic
- Subjects who present with wounds of etiology other than diabetes
- Subject demonstrates increased signs of clinical infection
- Has active malignant disease of any kind. A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry.
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 |
|---|---|---|
| INTEGRA™ Flowable Matrix (Collagen)Also: Integra Flowable Wound MatrixINTEGRA™ Flowable Wound Matrix is an advanced 3-D porous matrix comprised of granulated cross-linked bovine tendon collagen and glycosaminoglycan. It provides a scaffold for cellular invasion and capillary growth. The collagen and glycosaminoglycan mix is hydrated with saline and applied on the wound bed. | Drug | INTEGRA Flowable on wound & injected subcutaneously, Integra Flowable on wound bed |
Primary outcome
Overall Decrease in Wound Size
Time frame: 12 weeks
1 secondary outcome
Decreased Peak Plantar Pressures in Both the Static and Dynamic Phases of Gait as Compared to Pre-operative Pressure Values.
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Steinberg, DPM principal investigator
Georgetown University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing INTEGRA™ Flowable Matrix (Collagen) in people with Diabetes and Foot Ulcer, run by Georgetown University at 1 site in United States.
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 5 inclusion and 9 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 17 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Decrease in Wound Size (time frame: 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 17 Mar 2014.