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

NCT01490879 | Completed Phase 2 DMC

• 1 other identifier: NEX-ULC-011
• Study Type: interventional
• Target: 168
• Locations: 3 countries
• Sites: 25

Brief 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. Standard of care will include debridement of the ulcer, standardized dressings and standardized off-loading using a Removable Cast Walker.

Conditions

Diabetic Foot Ulcers

Keywords

DFU; Diabetic Foot Ulcer; Ulcers; Foot Ulcers; chronic wound; wounds; Nexagon; CoDa

Outcome Measures

Primary Outcomes (1)

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

  Within 12 weeks

Secondary Outcomes (5)

• Percentage change in RDFU surface area

  Within 12 weeks

• Time to RDFU complete closure

  Within 12 weeks

• Percentage of granulation tissue in RDFU

  12 weeks

• Incidence of ulcer recurrence

  12 weeks post-closure

• Incidence of adverse events

  12 weeks

Study Arms (4)

Nexagon® Low Dose

EXPERIMENTAL

Twice weekly applications of Nexagon® low dose in addition to off-loading using a Removable Cast Walker

Drug: Nexagon® Low Dose

Nexagon® Medium Dose

EXPERIMENTAL

Twice weekly applications of Nexagon® medium dose in addition to off-loading using a Removable Cast Walker

Drug: Nexagon® Medium Dose

Nexagon® High Dose

EXPERIMENTAL

Twice weekly applications of Nexagon® high dose in addition to off-loading using a Removable Cast Walker

Drug: Nexagon® High Dose

Nexagon® vehicle

PLACEBO COMPARATOR

Twice weekly applications of Nexagon® vehicle in addition to off-loading using a Removable Cast Walker

Drug: Nexagon® vehicle

Interventions

Nexagon® Low Dose DRUG

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

Nexagon® Low Dose

Nexagon® Medium Dose DRUG

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

Nexagon® Medium Dose

Nexagon® High Dose DRUG

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

Nexagon® High Dose

Nexagon® vehicle DRUG

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

Nexagon® vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Wound bed consisting of completely viable tissue or one where completely viable tissue will be achieved by the end of the screening period.
• 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.

You may not qualify if:

• 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.
• \. 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).
• \. 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.
• 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.
• \. 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.
• \. Severe Charcot deformity or rocker bottom foot with an associated plantar mid-foot or heel ulcer.
• \. 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.
• \. Requirement for concurrent topical antimicrobials to treat the RDFU after the end of the screening period.
• \. Received dermal substitute or living skin equivalent (e.g. Dermagraft® or Apligraf®) within 14 days prior of the start of the screening period.
• \. Severe complications of diabetes that in the opinion of the Investigator could interfere with wound healing or impede the subject's participation.
• \. Subjects on concurrent immunosuppressive therapy to include oral corticosteroid therapy equivalent to greater than 5 mg/day of prednisone.
• \. 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

Sponsors & Collaborators

• OcuNexus Therapeutics, Inc.: lead

Study Sites (25)

Associated Foot and Ankle Specialists, LLC

Phoenix, Arizona, 85015, United States

Location

University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

Center For Clinical Research Inc.

Castro Valley, California, 94546, United States

Location

Advanced Foot Care and Clinical Research Center

Fresno, California, 93722, United States

Location

Barry University Clinical Research

Hialeah, Florida, 33013, United States

Location

Univeristy of Miami, Miller School of Medicine, Dermatology Research

Miami, Florida, 33136, United States

Location

Doctors Research Network

South Miami, Florida, 33143, United States

Location

Advanced Foot and Ankle Center

Las Vegas, Nevada, 89119, United States

Location

Houston Foot and Ankle Care

Houston, Texas, 77074, United States

Location

Kemerovo Regional Clinical Hospital

Kemerovo, 650066, Russia

Location

City Clinical Hospital #13

Moscow, 1154280, Russia

Location

Endocrinology Science Center

Moscow, 117036, Russia

Location

Endocrinology Clinic of Moscow, Department of Healthcare

Moscow, 119034, Russia

Location

Moscow Medical University n.a.

Moscow, 119435, Russia

Location

Federal bureau of medical and social expertise, Moscow

Moscow, 127486, Russia

Location

St Petersburg City Hospital of St Elizabeth

Saint Petersburg, 198099, Russia

Location

St Petersburg Diagnostic Center

Saint Petersburg, 198255, Russia

Location

Voronezh Regional Clinical Consultative Diagnostic Center

Voronezh, Russia

Location

Cherkasy Regional Clinical Hospital, Endocrinology Department

Cherkasy, 18009, Ukraine

Location

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

Dnipropetrovsk, 49005, Ukraine

Location

Ivano-Frankivsk Central City Clinical Hospital

Ivano-Frankivsk, 76025, Ukraine

Location

Regional Clinical Hospital, Cardiovascular Surgery Department

Kharkiv, 61022, Ukraine

Location

Kyiv City Clinical Hospital #1

Kyiv, 02091, Ukraine

Location

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

Kyiv, 04114, Ukraine

Location

Zaporizhzhya City Clinical Hospital #9

Zaporizhzhya, 69096, Ukraine

Location

MeSH Terms

Conditions

Diabetic Foot; Ulcer; Foot Ulcer; Wounds and Injuries

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Foot Diseases

Study Officials

• David G Armstrong, DPM MD PhD

  S.A.L.S.A. , University of Arizona, Tucson, AZ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2011
• First Posted: December 13, 2011
• Study Start: July 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 1, 2014

Record last verified: 2014-04

Locations

US (9); UA (7); RU (9)