Neuropathic Diabetic Ulcer - FootNCT01060670

A Safety and Efficacy Study of INTEGRA® Dermal Regeneration Template for the Treatment of Diabetic Foot Ulcers

A study testing Integra® Dermal Regeneration Template and Conventional Wound Therapy in people with Neuropathic Diabetic Ulcer - Foot, run by Integra LifeSciences Corporation at 33 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to evaluate the safety and efficacy of the INTEGRA® Dermal Regeneration Template for the treatment of diabetic foot ulcers located distal to the malleolus in subjects with diabetes mellitus, neuropathy, 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: Neuropathic Diabetic Ulcer - Foot
What is being tested?: Integra® Dermal Regeneration Template and Conventional Wound Therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 545 participants
Where: 33 sitesin 2 countries
Study dates: Apr 2010to Jun 2014
Phase: Interventional
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

Type I or Type II diabetes mellitus
Glycosylated hemoglobin, HbA1c, ≤ 12%
Negative serum pregnancy test at screening for female participants of child-bearing potential
Willing and able to maintain the required off-loading (as applicable for the location for the ulcer) and applicable dressing changes
At least one DFU that met the following criteria:
Ulcer was diagnosed as a full-thickness neuropathic DFU that was located distal to the malleolus (excluding ulcers between the toes but including those of the heel),

Show all 12Show fewer

Minimum 2-cm margin between the qualifying study ulcer and any other ulcers on the specified foot (post debridement),
Area greater than or equal to 1 square centimeter and less than or equal to 12 square centimeters (post debridement at the time of randomization),
Wagner grade 1 or 2,
Depth less than or equal to 5 millimeters with no exposed capsule, tendon or bone and no tunneling, undermining or sinus tracts,
Duration of the study ulcer was at least 30 days at the time of the screening visit
Adequate vascular perfusion of the affected limb

Who cannot join

Suspected or confirmed signs/symptoms of gangrene or wound infection on any part of the limb
History of hypersensitivity to bovine collagen and/or chondroitin.
Pregnancy
Previous treatment under this clinical protocol
Participation in another clinical trial involving a device or systematically administered investigational study drug or treatment within 30 days of the randomization visit.
Receiving or scheduled to receive a medication or treatment which, in the opinion of the investigator, was known to interfere with, or affect the rate and quality of wound healing

Show all 18Show fewer

Any unstable condition or circumstance that could interfere with treatment regimen compliance
Excessive lymphedema that could interfere with wound healing
Unstable Charcot foot or Charcot with boney prominence
Ulcers secondary to a disease other than diabetes
Osteomyelitis with necrotic soft bone
Chopart amputation
History of bone cancer or metastatic disease of the affected limb, radiation therapy to the foot, or chemotherapy within the 12 months prior to randomization
Treatment with wound dressings that include growth factors, engineered tissues, or skin substitutes within 30 days of randomization or scheduled to receive such treatment during the study
Non-study ulcer requiring treatment that could not be treated during the study with moist wound therapy
History of or intercurrent illnesses or conditions (other than diabetes) that would compromise the safety of the subject, or the normal wound healing process
Employees or relatives of any member of the investigational site or sponsor
Size of the study ulcer following debridement decreased by more than 30% during the run in period

Trial locations and contacts

33 sites in 2 countries.

Country

City, postcode or hospital

33 sites in 2 countries

United States32 sites

Excelsior Foundation of WNY
Amherst, New York, 14226
Village Podiatry Center
Atlanta, Georgia, 30308
Stockdale Podiatry Group
Bakersfield, California, 93309
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744
Boston Medical Center
Boston, Massachusetts, 02118
Cambridge Health Alliance
Cambridge, Massachusetts, 02139
Center for Clinical Research
Castro Valley, California, 94546
Limb Salvage Center
Dallas, Texas, 75231
Department of Plastic Surgery
Dallas, Texas, 75390
Private Practice
East Setauket, New York, 11733
Diabetic Foot and Wound Treatment Center
El Centro, California, 92243
Penn North Center For Advanced Wound Care
Erie, Pennsylvania, 16544
Sacramento Foot and Ankle Center
Fair Oaks, California, 95628
Advanced Foot Care and Clinical Research Center
Fresno, California, 93722
Center for Clinical Research
Fresno, California, 94115
Idaho Falls Infectious Diseases, PLLC
Idaho Falls, Idaho, 83404
Infectious Disease of Indiana
Indianapolis, Indiana, 46260
Advanced Foot and Ankle Center
Las Vegas, Nevada, 89119
Benchmark Research
Metarie, Louisiana, 70006
Advanced Pharma CR, LLC
Miami, Florida, 33136
Montana Medical Research
Missoula, Montana, 59808
Costal Clinical Research
Mobile, Alabama, 36608
Columbia University Medical Center
New York, New York, 10034
California School of Podiatry Medicine at Samuel Merritt University
Oakland, California, 94609
Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, 19107
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Northern California Foot and Ankle Center
Santa Rosa, California, 95403
Springfield Clinic
Springfield, Illinois, 62703
Foot and Ankle Institute
St. George, Utah, 84770
South Florida Wound Care Group
Tamarac, Florida, 33321
C/O Center for Wound Care
Wellington, Florida, 33414

Other trials in United States

Netherlands Antilles1 site

St. Elisabeth's Hospital
Willemstad, Curacao

About this study

Official title: A Multi-Center, Randomized, Controlled Clinical Trial to Evaluate The Safety and Effectiveness of Integra® Dermal Regeneration Template for the Treatment of Neuropathic Diabetic Foot Ulcers

Conditions: Neuropathic Diabetic Ulcer - Foot
Being tested: Integra® Dermal Regeneration Template, Conventional Wound Therapy
Keywords: Foot Ulcer, Diabetic, Wound Healing, Integra Dermal Regeneration Template, Full Thickness, Neuropathic, Omnigraft
Medical subject headings: Foot Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Integra® Dermal Regeneration TemplateDevice
Application of Integra® Dermal Regeneration Template in diabetic foot ulcer
Conventional Wound TherapyOther
Conventional Wound Therapy

Study groups in NCT01060670
Study group	Role	What they receive
Dermal Replacement Device	Experimental	Device: INTEGRA® Dermal Regeneration Template Receives: Device: Integra® Dermal Regeneration Template
Moist Wound Therapy	Active comparator	0.9% Saline gel Receives: Other: Conventional Wound Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Complete Wound Closure
100% closure as assessed by the Investigator and confirmed at 2 consecutive treatment phase visits.
Measured: 16 weeks

Secondary outcomes (6)

Incidence of Complete Wound Closure
Percentage of subjects with complete wound closure of the study ulcer, as assessed by computerized planimetry, during the treatment phase.
Measured: 16 weeks
Time to Complete Wound Closure
Measures the time to complete wound closure as assessed by the Investigator.
Measured: 16 weeks
Time to Complete Wound Closure
Time to complete wound closure, as assessed by computerized planimetry.
Measured: 16 weeks
Rate of Wound Closure
Rate of wound closure as assessed by computerized planimetry
Measured: 16 weeks
Incidence of Ulcer Recurrence
Measures the incidence of ulcer recurrence at the site of the study ulcer during the follow up phase.
Measured: 12 weeks
Change in Short Form Health Survey (SF-36) Quality of Life Metrics
Short Form Health Survey (SF-36)- Quality of Life Metrics. The SF-36 was utilized and the Physical Function and Bodily Pain subscales were norm-based, with a Mean = 50, SD = 10. Scores could theoretically range from 0 to 100, with higher scores indicating a better health status.
Measured: Baseline and 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Jun 2014

First posted2 Feb 2010 (estimated)
Study startApr 2010
Primary completionJun 2014
Study completionJun 2014

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 Neuropathic Diabetic Ulcer - FootStudies 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: None (open label)
Enrolment: 545 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01060670
Sponsor's protocol ID: IDRT/DFU US - 2009-3
Status last verified: Jul 2016
First submitted: 31 Jan 2010
Last updated: 22 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Comparative Study of Combination Treatment of Bionerv E+ Versus Vitamin B Complex in Treatment of Diabetic Polyneuropathy in Type 2 Diabetic Patients and Its Effect on Wound Healing
Diabetic Foot Ulcer (DFU), Diabetic Symmetrical Polyneuropathy
RecruitingEarly Phase 1
Efficacy of a Topical Palmitated Formulation of Capsaicin (Capsadyn®) In the Treatment of Diabetic Neuropathic Foot Pain
Diabetic Neuropathies, Painful, Diabetic Foot
Enrolling by invitation
Using Lymphovenous Bypass to Alleviate Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN), Diabetic Peripheral Neuropathic Pain (DPNP)
Recruiting
Diabetic Foot Ulcer Research Study
Diabetic Foot Ulcer, Diabetic Foot Ulcer Neuropathic
Not yet recruiting
The Instant Effect of Whole Body Vibration in Diabetics
Diabetus Mellitus, Diabetic Foot Ulcer

All Neuropathic Diabetic Ulcer - Foot trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Randomized, Controlled Clinical Trial to Evaluate The Safety and Effectiveness of Integra® Dermal Regeneration Template for the Treatment of Neuropathic Diabetic Foot Ulcers
ClinicalTrials.gov ID: NCT01060670
Acronym / sponsor ID: IDRT/DFU US - 2009-3
Conditions: Neuropathic Diabetic Ulcer - Foot
Keywords: Foot Ulcer, Diabetic, Wound Healing, Integra Dermal Regeneration Template, Full Thickness, Neuropathic, Omnigraft
Study type: Interventional
Recruitment status: Completed
Enrolment: 545 participants (actual)
Lead sponsor: Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 2 Feb 2010 (estimated)
Results: Posted 22 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dermal Replacement Device	Experimental	Device: Integra® Dermal Regeneration TemplateDevice: INTEGRA® Dermal Regeneration Template
Moist Wound Therapy	Active comparator	Other: Conventional Wound Therapy0.9% Saline gel

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Type I or Type II diabetes mellitus
Glycosylated hemoglobin, HbA1c, ≤ 12%
Negative serum pregnancy test at screening for female participants of child-bearing potential
Willing and able to maintain the required off-loading (as applicable for the location for the ulcer) and applicable dressing changes
At least one DFU that met the following criteria:

Key exclusion criteria (18 listed)

Suspected or confirmed signs/symptoms of gangrene or wound infection on any part of the limb
History of hypersensitivity to bovine collagen and/or chondroitin.
Pregnancy
Previous treatment under this clinical protocol
Participation in another clinical trial involving a device or systematically administered investigational study drug or treatment within 30 days of the randomization visit.

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® Dermal Regeneration TemplateApplication of Integra® Dermal Regeneration Template in diabetic foot ulcer	Device	Dermal Replacement Device
Conventional Wound TherapyConventional Wound Therapy	Other	Moist Wound Therapy

Primary outcome

Incidence of Complete Wound Closure
Time frame: 16 weeks
100% closure as assessed by the Investigator and confirmed at 2 consecutive treatment phase visits.

6 secondary outcomes

Incidence of Complete Wound Closure
Time frame: 16 weeks
Time to Complete Wound Closure
Time frame: 16 weeks
Time to Complete Wound Closure
Time frame: 16 weeks
Rate of Wound Closure
Time frame: 16 weeks
Incidence of Ulcer Recurrence
Time frame: 12 weeks
Change in Short Form Health Survey (SF-36) Quality of Life Metrics
Time frame: Baseline and 16 weeks

Results and safety

Results posted to the registry on 22 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Treatment	0	0
Control Treatment	545	307

Primary outcome: Incidence of Complete Wound Closure

Time frame: 16 weeks. Number. Unit: participants

Measure	Active Treatment n = 154	Control Treatment n = 153
Value	79	49

Population analysed: The results were based on the Investigator assessment and ITT population.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: All events starting after the 1st randomized treatment visit through Follow Up visit 3 will be recorded as AEs.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Treatment	38 of 154 (24.7%)	0 of 154 (0%)	Not reported
Control Treatment	55 of 153 (35.9%)	0 of 153 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Neuropathic Diabetic Ulcer - Foot

Recruiting
Comparative Study of Combination Treatment of Bionerv E+ Versus Vitamin B Complex in Treatment of Diabetic Polyneuropathy in Type 2 Diabetic Patients and Its Effect on Wound Healing
Diabetic Foot Ulcer (DFU), Diabetic Symmetrical Polyneuropathy
RecruitingEarly Phase 1
Efficacy of a Topical Palmitated Formulation of Capsaicin (Capsadyn®) In the Treatment of Diabetic Neuropathic Foot Pain
Diabetic Neuropathies, Painful, Diabetic Foot
Enrolling by invitation
Using Lymphovenous Bypass to Alleviate Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN), Diabetic Peripheral Neuropathic Pain (DPNP)
Recruiting
Diabetic Foot Ulcer Research Study
Diabetic Foot Ulcer, Diabetic Foot Ulcer Neuropathic
Not yet recruiting
The Instant Effect of Whole Body Vibration in Diabetics
Diabetus Mellitus, Diabetic Foot Ulcer

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.

The record lists no contact. Use the official record to reach the sponsor.

33 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 18 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: finished, as of the sponsor's last update on 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, Netherlands Antilles. 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?

Yes. Results are posted in the registry (first posted 22 Sep 2016). 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?

Incidence of Complete Wound Closure (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01060670.

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 22 Sep 2016.