- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00820703
The ASCEND Study: A Study to Investigate the Safety and Clinical Effect of Nexagon to Treat Slow Healing Diabetic Foot Ulcers
August 29, 2010 updated by: OcuNexus Therapeutics, Inc.
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Auckland, New Zealand
- Middlemore Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To evaluate the safety and clinical effect of Nexagon® administered topically to diabetic foot ulcers.
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Secondary Outcome Measures
Outcome Measure |
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To select the optimal dose(s) which can be used in future trials of Nexagon® in diabetic foot ulcers
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To pilot the collection of data that may be considered useful in planning future studies of Nexagon® administered topically to diabetic foot ulcers.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
January 8, 2009
First Submitted That Met QC Criteria
January 8, 2009
First Posted (Estimate)
January 12, 2009
Study Record Updates
Last Update Posted (Estimate)
August 31, 2010
Last Update Submitted That Met QC Criteria
August 29, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEX-ULC-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Foot Ulcer
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University of MinnesotaRecruitingDiabetes Mellitus | Foot Ulcer | Ulcer | Diabetic Foot Ulcer | Foot Ulcer, Diabetic | Ulcer Foot | Ulcer, Leg | Ankle UlcerUnited States
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Community Pharmacology Services LtdKeneric HealthcareNot yet recruitingDiabetic Foot Ulcer | Diabetic Foot Ulcer Neuropathic | Diabetic Foot Ulcer Ischemic
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University of PadovaUnknownDiabetic Foot | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Neuropathic | Deformities FootItaly
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Corporacion Parc TauliCompletedDiabetic Foot Ulcer | Diabetic Foot Ulcer NeuropathicPakistan
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Johns Hopkins UniversityWithdrawnDiabetic Foot | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Mixed | Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot)
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Baylor College of MedicineLifeNet HealthCompletedDiabetic Foot Ulcer | Deep Diabetic Foot UlcerUnited States
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ETS Wound Care, LLCProfessional Education and Research InstituteCompletedDiabetic Foot | Diabetic Foot Ulcer | Ulcer FootUnited States
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Exciton Technologies Inc.CompletedDiabetic Foot Ulcer | Diabetic Foot Infection | Non-healing Diabetic Foot UlcerCanada
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National and Kapodistrian University of AthensTerminatedDiabetic Foot | Chronic Diabetic Foot Ulcer of Right Foot | Neuropathic Foot Ulcer | Chronic Diabetic Ulcer of Left Foot (Diagnosis)Greece
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University of the PunjabHigher Education Commission (Pakistan); Centre of Excellence in Molecular Biology... and other collaboratorsRecruitingDiabetes Mellitus | Diabetic Foot | Foot Ulcer | Diabetes Complications | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Neuropathic | Foot Ulcer Due to Type 1 Diabetes Mellitus | Foot Ulcer Due to Type 2 Diabetes Mellitus | Chronic Diabetic Ulcer of Left Foot | Chronic Diabetic Foot...Pakistan
Clinical Trials on Nexagon®
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OcuNexus Therapeutics, Inc.CompletedVenous UlcerNew Zealand, United States
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OcuNexus Therapeutics, Inc.CompletedDiabetic Foot UlcersRussian Federation, United States, Ukraine
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OcuNexus Therapeutics, Inc.WithdrawnPersistent Epithelial Defect
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OcuNexus Therapeutics, Inc.CompletedVenous Leg UlcersUnited States, New Zealand, South Africa, Australia
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Amber Ophthalmics, Inc.RecruitingCorneal Persistent Epithelial DefectUnited States
-
Amber Ophthalmics, Inc.RecruitingPersistent Corneal Epithelial DefectUnited States
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OcuNexus Therapeutics, Inc.CompletedCorneal re-EpithelializationNew Zealand
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OcuNexus Therapeutics, Inc.Completed
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The Cleveland ClinicNovartisCompleted
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University of California, San FranciscoFDA Office of Orphan Products DevelopmentTerminatedPersistent Corneal Epithelial Defects