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The ASCEND Study: A Study to Investigate the Safety and Clinical Effect of Nexagon to Treat Slow Healing Diabetic Foot Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00820703
Recruitment Status : Terminated (For business reasons)
First Posted : January 12, 2009
Last Update Posted : August 31, 2010
Information provided by:
OcuNexus Therapeutics, Inc.

Brief Summary:
Diabetic foot ulcers are sores on the feet that occur in 15% of diabetic patients some time during their lifetime. Once an ulcer develops, the risk of lower-extremity amputation is increased 8-fold in people with diabetes. New treatments that improve the number of ulcers that heal and/or speed up healing are urgently needed. Initial studies with a new drug called Nexagon® (developed by CoDa Therapeutics, Inc.) support the concept that healing of diabetic foot ulcers can be improved with topical application of Nexagon®. Further research will be undertaken to assess the safety and activity of Nexagon® when applied to diabetic foot ulcers at various doses. A proposed randomized controlled trial will randomly allocate (e.g., by the toss of a coin) 24 people with diabetic foot ulcers to Nexagon® (one of three different doses) or vehicle (substance containing no medication) to be applied to their ulcer three times over four weeks. Participants will be followed over four weeks to monitor their response to the treatment, specifically with regards to the amount of healing that occurs.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Drug: Nexagon® Drug: Nexagon® vehicle Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Prospective, Double-blind, Vehicle-controlled, Dose-escalation, Single-center Study of the Safety and Clinical Effect of Nexagon® in the Treatment of Participants With Diabetic Foot Ulcers
Study Start Date : April 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To evaluate the safety and clinical effect of Nexagon® administered topically to diabetic foot ulcers.

Secondary Outcome Measures :
  1. To select the optimal dose(s) which can be used in future trials of Nexagon® in diabetic foot ulcers
  2. To pilot the collection of data that may be considered useful in planning future studies of Nexagon® administered topically to diabetic foot ulcers.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female aged 18 and older
  2. Female subjects must be a) post-menopausal, b) surgically sterilized, c) practicing abstinence, or d) using hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study
  3. Diabetes mellitus (type I or II) with an HbA1c < 10.0%
  4. Diagnosis of neuropathic foot ulcer
  5. Cutaneous, full thickness (University of Texas grade A1), below ankle surface ulcer between 0.5 and 5.0 cm2 post-debridement
  6. A viable, granulating wound
  7. Ulcer present for > 4 weeks prior to study entry
  8. An ankle brachial index between 0.70 and 1.3 measured during screening or within three months prior to the Day -14 visit
  9. Signed informed consent form

Exclusion Criteria:

  1. Decrease or increase in the ulcer size by 30% or more during a14 day "run-in" period
  2. Cannot tolerate the off-loading method or comply with standard-of-care
  3. An ulcer which shows signs of clinical infection
  4. The ulcer to be treated requires operative debridement.
  5. An ulcer positive for β-hemolytic streptococcus upon culture.
  6. Requirement for total contact casts
  7. The ulcer has more than 50% slough, significant necrotic tissue, osteomyelitis, bone, tendon, or capsule exposure
  8. Presence of an active systemic or local cancer or tumor of any kind (with the exception of non-melanoma skin cancer)
  9. Congestive heart failure NYHA class II - IV
  10. Coronary heart disease with STEMI, CABG, or PTCA within the last 6 months
  11. Active osteomyelitis of the study foot
  12. Active connective tissue disease
  13. Acute Charcot's neuroarthropathy as determined by clinical and/or radiographic examination
  14. Treatment with systemic corticosteroids (
  15. Previous or current radiation therapy to the distal lower extremity or likelihood to receive this therapy during study participation
  16. Pregnancy or lactation
  17. eGFR < 25 mL/min
  18. Poor nutritional status defined as an albumin < 25 g/L
  19. Significant peripheral edema
  20. Known prior inability to complete required study visits during study participation
  21. A psychiatric condition (e.g., suicidal ideation) or chronic alcohol or drug abuse problem, determined from the subject's medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance
  22. Use of a platelet-derived growth factor within the 28 days prior to screening
  23. Use of any investigational drug or therapy within the 28 days prior to screening
  24. Any other factor which may, in the opinion of the Investigator, compromise participation and follow-up in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00820703

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New Zealand
Middlemore Hospital
Auckland, New Zealand
Sponsors and Collaborators
OcuNexus Therapeutics, Inc.
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Responsible Party: Scott Bannan, CoDa Therapeutics Identifier: NCT00820703    
Other Study ID Numbers: NEX-ULC-003
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: August 31, 2010
Last Verified: August 2010
Keywords provided by OcuNexus Therapeutics, Inc.:
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases