Status:
TERMINATED
The ASCEND Study: A Study to Investigate the Safety and Clinical Effect of Nexagon to Treat Slow Healing Diabetic Foot Ulcers
Lead Sponsor:
OcuNexus Therapeutics, Inc.
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- Male or female aged 18 and older
- 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
- Diabetes mellitus (type I or II) with an HbA1c \< 10.0%
- Diagnosis of neuropathic foot ulcer
- Cutaneous, full thickness (University of Texas grade A1), below ankle surface ulcer between 0.5 and 5.0 cm2 post-debridement
- A viable, granulating wound
- Ulcer present for \> 4 weeks prior to study entry
- An ankle brachial index between 0.70 and 1.3 measured during screening or within three months prior to the Day -14 visit
- Signed informed consent form
Exclusion
- Decrease or increase in the ulcer size by 30% or more during a14 day "run-in" period
- Cannot tolerate the off-loading method or comply with standard-of-care
- An ulcer which shows signs of clinical infection
- The ulcer to be treated requires operative debridement.
- An ulcer positive for β-hemolytic streptococcus upon culture.
- Requirement for total contact casts
- The ulcer has more than 50% slough, significant necrotic tissue, osteomyelitis, bone, tendon, or capsule exposure
- Presence of an active systemic or local cancer or tumor of any kind (with the exception of non-melanoma skin cancer)
- Congestive heart failure NYHA class II - IV
- Coronary heart disease with STEMI, CABG, or PTCA within the last 6 months
- Active osteomyelitis of the study foot
- Active connective tissue disease
- Acute Charcot's neuroarthropathy as determined by clinical and/or radiographic examination
- Treatment with systemic corticosteroids (
- Previous or current radiation therapy to the distal lower extremity or likelihood to receive this therapy during study participation
- Pregnancy or lactation
- eGFR \< 25 mL/min
- Poor nutritional status defined as an albumin \< 25 g/L
- Significant peripheral edema
- Known prior inability to complete required study visits during study participation
- 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
- Use of a platelet-derived growth factor within the 28 days prior to screening
- Use of any investigational drug or therapy within the 28 days prior to screening
- Any other factor which may, in the opinion of the Investigator, compromise participation and follow-up in this study
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00820703
Start Date
April 1 2009
End Date
December 1 2009
Last Update
August 31 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Middlemore Hospital
Auckland, Auckland, New Zealand