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

This study has been terminated.
(For business reasons)
Sponsor:
Information provided by:
CoDa Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00820703
First received: January 8, 2009
Last updated: August 29, 2010
Last verified: August 2010
  Purpose

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 Intervention Phase
Diabetic Foot Ulcer
Drug: Nexagon®
Drug: Nexagon® vehicle
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by CoDa Therapeutics Inc.:

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

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

Estimated Enrollment: 24
Study Start Date: April 2009
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820703

Locations
New Zealand
Middlemore Hospital
Auckland, New Zealand
Sponsors and Collaborators
CoDa Therapeutics Inc.
  More Information

No publications provided

Responsible Party: Scott Bannan, CoDa Therapeutics
ClinicalTrials.gov Identifier: NCT00820703     History of Changes
Other Study ID Numbers: NEX-ULC-003
Study First Received: January 8, 2009
Last Updated: August 29, 2010
Health Authority: New Zealand: Medsafe

Keywords provided by CoDa Therapeutics Inc.:
Nexagon
CoDa
ulcer
diabetic
foot

Additional relevant MeSH terms:
Foot Ulcer
Diabetic Foot
Foot Diseases
Ulcer
Pathologic Processes
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on August 20, 2014