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Diabetic Foot UlcersPhase 2DUNENCT01490879

A Study to Investigate the Safety and Clinical Effect of Nexagon® as a Topical Treatment for Subjects With a Diabetic Foot Ulcer (DUNE)

A Phase 2 study testing Nexagon® Low Dose, Nexagon® Medium Dose and Nexagon® High Dose in people with Diabetic Foot Ulcers, run by OcuNexus Therapeutics, Inc. at 25 sites in 3 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

This study is for Type I or Type II diabetic subjects with with a diabetic foot ulcer. The study is being done to determine if Nexagon® plus standard of care is more effective than placebo plus standard of care. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Foot Ulcers
What is being tested?
Nexagon® Low Dose, Nexagon® Medium Dose and Nexagon® High Dose
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
168 participants
Where
25 sitesin 3 countries
Study dates
Jul 2012to Apr 2014
Phase
Phase 2
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

  • Diagnosis of diabetes mellitus (Type I or II)
  • HbA1c of less than or equal to 12.0%
  • Diagnosis of neuropathic foot ulcer with partial or complete neuropathy
  • Cutaneous ulcer on the plantar or dorsal aspect of the foot or toe that is greater or equal to 1.0cm2 and less than or equal to 8.0 cm2 in area at the end of the screening period and is full thickness with no exposed ligament, tendon, joint capsule or bone. Surface area will be measured by digital planimetry.
  • The Medical Monitor(or delegate)must confirm that the reference diabetic foot ulcer (RDFU)is suitable for inclusion after reviewing digital photographs
  • Wound bed consisting of completely viable tissue or one where completely viable tissue will be achieved by the end of the screening period.
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  • An Ankle Branchial Index (ABI) of greater or equal to 0.80 in concert with a bi- or tri-phasic Doppler flow pattern; or adequate circulation as demonstrated by any of the following methods: peri-wound transcutaneous partial pressure oxygen (TcpO2)greater or equal to 40 mmHg; or a toe pressure of greater or equal to 40 mmHg; or skin perfusion pressure of greater or equal to 40 mmHg.
  • Ulcer present for 4 weeks or more or less than or equal to 12 months.
  • Willing to wear a Removable Cast Walker (RCW) between study visits for the duration of the study.
  • Signed informed consent form.

Who cannot join

  • Any unstable medical condition that would cause the study to be detrimental to the subject.
  • Decrease in RDFU size by more than 40% or increase in the ulcer size by more than 40% during the 14-day screening period as measured by digital planimetry.
  • Ulcers caused primarily by untreated vascular insufficiency or ulcers with an etiology not related to diabetes.4. Ulcers above the ankle.
  • 5. Ulcers that cannot be effectively off-loaded using the cast walker and sole insert provided in this study (ulcers not located on the weight bearing surface of the foot do not require off-loading).
  • 6. Ulcers on the toes not accessible for photography (e.g. in the web space). 7. Presence of other ulcers within 2cm of the perimeter of the RDFU. 8. BMI > 45 9. Cannot tolerate or will not comply with the off-loading method, or non-compliance with standard or care.
  • 10.The RDFU is infected (clinical assessment of infection)and/or biopsy proof of greater than 100,000 organisms per gram of tissue during the screening period.
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  • 11. Subjects presenting with the clinical characteristics of cellulitis at the ulcer site. 12. Necrosis, purulence, or sinus tracts that cannot be removed by debridement.13. Definite or suspected osteomyelitis within any wound located anywhere on the subjects body.14. Acute Charcot's neuroarthropathy as determined by clinical and/or previous radiographic examination.
  • 15. Severe Charcot deformity or rocker bottom foot with an associated plantar mid-foot or heel ulcer.
  • 16. Revascularization surgery on the leg with the wound to be treated less than or equal to 4 weeks prior to the start of the screening period.
  • 17. Requirement for concurrent topical antimicrobials to treat the RDFU after the end of the screening period.
  • 18. Received dermal substitute or living skin equivalent (e.g. Dermagraft® or Apligraf®) within 14 days prior of the start of the screening period.
  • 19. Severe complications of diabetes that in the opinion of the Investigator could interfere with wound healing or impede the subject's participation.
  • 20. Subjects on concurrent immunosuppressive therapy to include oral corticosteroid therapy equivalent to greater than 5 mg/day of prednisone.
  • 21. Any history of radiation therapy to the foot. 22. Female subjects who are pregnant or lactating. 23. Pre-menopausal women not using effective birth control methods as determined by the Investigator. 24. Life expectancy of < 12 months. 25. Subjects on renal replacement therapy. 26. Cancer within the last 3 years except basal and squamous cell carcinoma. 27. Cancer within the RDFU

Trial locations and contacts

25 sites in 3 countries.

25 sites in 3 countries

United States9 sites

  • Center For Clinical Research Inc.

    Castro Valley, California, 94546

  • Advanced Foot Care and Clinical Research Center

    Fresno, California, 93722

  • Barry University Clinical Research

    Hialeah, Florida, 33013

  • Houston Foot and Ankle Care

    Houston, Texas, 77074

  • Advanced Foot and Ankle Center

    Las Vegas, Nevada, 89119

  • Univeristy of Miami, Miller School of Medicine, Dermatology Research

    Miami, Florida, 33136

  • Associated Foot and Ankle Specialists, LLC

    Phoenix, Arizona, 85015

  • Doctors Research Network

    South Miami, Florida, 33143

  • University of Arizona Medical Center

    Tucson, Arizona, 85724

Other trials in United States

Russia9 sites

  • Kemerovo Regional Clinical Hospital

    Kemerovo, 650066

  • City Clinical Hospital #13

    Moscow, 1154280

  • Endocrinology Science Center

    Moscow, 117036

  • Endocrinology Clinic of Moscow, Department of Healthcare

    Moscow, 119034

  • Moscow Medical University n.a.

    Moscow, 119435

  • Federal bureau of medical and social expertise, Moscow

    Moscow, 127486

  • St Petersburg City Hospital of St Elizabeth

    Saint Petersburg, 198099

  • St Petersburg Diagnostic Center

    Saint Petersburg, 198255

  • Voronezh Regional Clinical Consultative Diagnostic Center

    Voronezh

Other trials in Russia

Ukraine7 sites

  • Cherkasy Regional Clinical Hospital, Endocrinology Department

    Cherkasy, 18009

  • Dnipropetrovsk Regional Clinical Hospitaln. a. I.I. Mechnikov

    Dnipropetrovsk, 49005

  • Ivano-Frankivsk Central City Clinical Hospital

    Ivano-Frankivsk, 76025

  • Regional Clinical Hospital, Cardiovascular Surgery Department

    Kharkiv, 61022

  • Kyiv City Clinical Hospital #1

    Kyiv, 02091

  • Institute of Endocrinology and Methabolism n.a. V.P. Komisarenko, Clinical Diabetology Department

    Kyiv, 04114

  • Zaporizhzhya City Clinical Hospital #9

    Zaporizhzhya, 69096

Other trials in Ukraine

About this study

Official title: A Randomized, Prospective, Double-blind, Vehicle-controlled, Dose-ranging, Multi-center Study to Assess the Safety and Clinical Effect of Nexagon® in the Treatment of Subjects With a Diabetic Foot Ulcer

This study is for Type I or Type II diabetic subjects with with a diabetic foot ulcer. The study is being done to determine if Nexagon® plus standard of care is more effective than placebo plus standard of care. Standard of care will include debridement of the ulcer, standardized dressings and standardized off-loading using a Removable Cast Walker.

Being tested
Nexagon® Low Dose, Nexagon® Medium Dose, Nexagon® High Dose, Nexagon® vehicle
Keywords
DFU, Diabetic Foot Ulcer, Ulcers, Foot Ulcers, chronic wound, wounds, Nexagon, CoDa
Medical subject headings
Diabetic Foot, Ulcer, Foot Ulcer, Wounds and Injuries

What participants receive

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

  • Nexagon® Low DoseDrug

    Twice weekly, topical application of Nexagon® low dose in addition to a Removable Cast Walker

  • Nexagon® Medium DoseDrug

    Twice weekly, topical application of Nexagon® medium dose in addition to a Removable Cast Walker

  • Nexagon® High DoseDrug

    Twice weekly, topical application of Nexagon® high dose in addition to a Removable Cast Walker

  • Nexagon® vehicleDrug

    Twice weekly, topical application of Nexagon® vehicle in addition to a Removable Cast Walker

Study groups in NCT01490879
Study groupRoleWhat they receive
Nexagon® Low DoseExperimentalTwice weekly applications of Nexagon® low dose in addition to off-loading using a Removable Cast Walker
Receives: Drug: Nexagon® Low Dose
Nexagon® Medium DoseExperimentalTwice weekly applications of Nexagon® medium dose in addition to off-loading using a Removable Cast Walker
Receives: Drug: Nexagon® Medium Dose
Nexagon® High DoseExperimentalTwice weekly applications of Nexagon® high dose in addition to off-loading using a Removable Cast Walker
Receives: Drug: Nexagon® High Dose
Nexagon® vehiclePlacebo comparatorTwice weekly applications of Nexagon® vehicle in addition to off-loading using a Removable Cast Walker
Receives: Drug: Nexagon® vehicle

What is being measured

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

  1. Incidence of Reference Diabetic Foot Ulcer (RDFU) complete closure determined by Investigator Assessment

    Measured: Within 12 weeks

Secondary outcomes (5)

  1. Percentage change in RDFU surface area

    Measured: Within 12 weeks

  2. Time to RDFU complete closure

    Measured: Within 12 weeks

  3. Percentage of granulation tissue in RDFU

    Measured: 12 weeks

  4. Incidence of ulcer recurrence

    Measured: 12 weeks post-closure

  5. Incidence of adverse events

    Measured: 12 weeks

Timeline

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

  1. First posted13 Dec 2011 (estimated)
  2. Study startJul 2012
  3. Primary completionFeb 2014
  4. Study completionApr 2014

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01490879
Sponsor's protocol ID
NEX-ULC-011
Acronym
DUNE
Status last verified
Apr 2014
First submitted
11 Dec 2011
Last updated
1 May 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nexagon® Low Dose, Nexagon® Medium Dose and Nexagon® High Dose in people with Diabetic Foot Ulcers, run by OcuNexus Therapeutics, Inc. at 25 sites in 3 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 10 inclusion and 14 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 1 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Russia, Ukraine. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Reference Diabetic Foot Ulcer (RDFU) complete closure determined by Investigator Assessment (time frame: Within 12 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 NCT01490879.

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 1 May 2014.

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