Clinical trial NCT01490879: A Study to Investigate the Safety and Clinical Effect of Nexagon® as a Topical Treatment for Subjects With a Diabetic Foot Ulcer (DUNE)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Foot Ulcers
Keywords: DFU
Diabetic Foot Ulcer
Ulcers
Foot Ulcers
chronic wound
wounds
Nexagon
CoDa
Lead sponsor: OcuNexus Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-13
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of diabetes mellitus (Type I or II)
2. HbA1c of less than or equal to 12.0%
3. Diagnosis of neuropathic foot ulcer with partial or complete neuropathy
4. 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.
5. The Medical Monitor(or delegate)must confirm that the reference diabetic foot ulcer (RDFU)is suitable for inclusion after reviewing digital photographs
6. Wound bed consisting of completely viable tissue or one where completely viable tissue will be achieved by the end of the screening period.
7. 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.
8. Ulcer present for 4 weeks or more or less than or equal to 12 months.
9. Willing to wear a Removable Cast Walker (RCW) between study visits for the duration of the study.
10. Signed informed consent form.

Exclusion Criteria:

1. Any unstable medical condition that would cause the study to be detrimental to the subject.
2. 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.
3. 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.

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

Primary outcomes:
measure: Incidence of Reference Diabetic Foot Ulcer (RDFU) complete closure determined by Investigator Assessment
timeFrame: Within 12 weeks
Secondary outcomes:
measure: Percentage change in RDFU surface area
timeFrame: Within 12 weeks
measure: Time to RDFU complete closure
timeFrame: Within 12 weeks
measure: Percentage of granulation tissue in RDFU
timeFrame: 12 weeks
measure: Incidence of ulcer recurrence
timeFrame: 12 weeks post-closure
measure: Incidence of adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Associated Foot and Ankle Specialists, LLC
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Medical Center
state: Arizona
city: Castro Valley
country: United States
facility: Center For Clinical Research Inc.
state: California
city: Fresno
country: United States
facility: Advanced Foot Care and Clinical Research Center
state: California
city: Hialeah
country: United States
facility: Barry University Clinical Research
state: Florida
city: Miami
country: United States
facility: Univeristy of Miami, Miller School of Medicine, Dermatology Research
state: Florida
city: South Miami
country: United States
facility: Doctors Research Network
state: Florida
city: Las Vegas
country: United States
facility: Advanced Foot and Ankle Center
state: Nevada
city: Houston
country: United States
facility: Houston Foot and Ankle Care
state: Texas
city: Kemerovo
country: Russian Federation
facility: Kemerovo Regional Clinical Hospital
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #13
city: Moscow
country: Russian Federation
facility: Endocrinology Science Center
city: Moscow
country: Russian Federation
facility: Endocrinology Clinic of Moscow, Department of Healthcare
city: Moscow
country: Russian Federation
facility: Moscow Medical University n.a.
city: Moscow
country: Russian Federation
facility: Federal bureau of medical and social expertise, Moscow
city: St Petersburg
country: Russian Federation
facility: St Petersburg City Hospital of St Elizabeth
city: St Petersburg
country: Russian Federation
facility: St Petersburg Diagnostic Center
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Consultative Diagnostic Center
city: Cherkasy
country: Ukraine
facility: Cherkasy Regional Clinical Hospital, Endocrinology Department
city: Dnipropetrovsk
country: Ukraine
facility: Dnipropetrovsk Regional Clinical Hospitaln. a. I.I. Mechnikov
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Central City Clinical Hospital
city: Kharkiv
country: Ukraine
facility: Regional Clinical Hospital, Cardiovascular Surgery Department
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #1
city: Kyiv
country: Ukraine
facility: Institute of Endocrinology and Methabolism n.a. V.P. Komisarenko, Clinical Diabetology Department
city: Zaporizhzhya
country: Ukraine
facility: Zaporizhzhya City Clinical Hospital #9
Study officials:
affiliation: S.A.L.S.A. , University of Arizona, Tucson, AZ
name: David G Armstrong, DPM MD PhD
role: PRINCIPAL_INVESTIGATOR
References: