Back to resultsThe ASCEND Study: A Study to Investigate the Safety and Clinical Effect of Nexagon to Treat Slow Healing Diabetic Foot Ulcers
Primary Purpose
Diabetic Foot Ulcer
Status
Terminated
Phase
Phase 1
Locations
New Zealand
Study Type
Interventional
Intervention
Nexagon®
Nexagon® vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Nexagon, CoDa, ulcer, diabetic, foot
Eligibility Criteria
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
Sites / Locations
- Middlemore Hospital
Outcomes
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.
Full Information
NCT ID
NCT00820703
First Posted
January 8, 2009
Last Updated
August 29, 2010
Sponsor
OcuNexus Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00820703
Brief Title
The ASCEND Study: A Study to Investigate the Safety and Clinical Effect of Nexagon to Treat Slow Healing Diabetic Foot Ulcers
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 Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Terminated
Why Stopped
For business reasons
Study Start Date
April 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
OcuNexus Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
Nexagon, CoDa, ulcer, diabetic, foot
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Nexagon®
Intervention Type
Drug
Intervention Name(s)
Nexagon® vehicle
Primary Outcome Measure Information:
Title
To evaluate the safety and clinical effect of Nexagon® administered topically to diabetic foot ulcers.
Secondary Outcome Measure Information:
Title
To select the optimal dose(s) which can be used in future trials of Nexagon® in diabetic foot ulcers
Title
To pilot the collection of data that may be considered useful in planning future studies of Nexagon® administered topically to diabetic foot ulcers.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Middlemore Hospital
City
Auckland
Country
New Zealand
12. IPD Sharing Statement
Learn more about this trial
The ASCEND Study: A Study to Investigate the Safety and Clinical Effect of Nexagon to Treat Slow Healing Diabetic Foot Ulcers
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