Diabetic Foot UlcerPhase 1/2NCT00820703
The ASCEND Study: A Study to Investigate the Safety and Clinical Effect of Nexagon to Treat Slow Healing Diabetic Foot Ulcers
A Phase 1/2 study testing Nexagon® in people with Diabetic Foot Ulcer, run by OcuNexus Therapeutics, Inc. at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Nexagon®
- How many people
- 24 participants
- Where
- 1 siteNew Zealand
- Study dates
- Apr 2009to Dec 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Nexagon®, Nexagon® vehicle
- Keywords
- Nexagon, CoDa, ulcer, diabetic, foot
- Medical subject headings
- Diabetic Foot, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexagon®Drug
Nexagon® vehicleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and clinical effect of Nexagon® administered topically to diabetic foot ulcers.
Secondary outcomes (2)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startApr 2009
- Primary completionNov 2009
- Study completionDec 2009
Why it stopped: For business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OcuNexus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820703
- Sponsor's protocol ID
- NEX-ULC-003
- Status last verified
- Aug 2010
- First submitted
- 8 Jan 2009
- Last updated
- 31 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00820703
- Acronym / sponsor ID
- NEX-ULC-003
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Nexagon, CoDa, ulcer, diabetic, foot
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: For business reasons
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- OcuNexus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 12 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nexagon® | Drug | – |
| Nexagon® vehicle | Drug | – |
Primary outcome
To evaluate the safety and clinical effect of Nexagon® administered topically to diabetic foot ulcers.
2 secondary outcomes
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.
Results and safety
The study was stopped early (reason given: For business reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2010.
Related trials for Diabetic Foot Ulcer
RecruitingPhase 2
Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
Diabetic Foot Ulcer
RecruitingObservational study
Efficacy and Safety of a Nitric Oxide Generating Dressing for Diabetic Foot Ulcers (ONWARD)
Diabetic Foot Ulcers (DFUs)
Not yet recruitingPhase 1
Placental Cells for Diabetic Foot Ulcers
Diabetic Foot Ulcer
RecruitingObservational study
Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
Charcot Joint of Foot, Osteoarthropathy
Not yet recruiting
Subcutaneous Dexpanthenol Administration and Wound Epithelialization
Chronic Wounds, Diabetic Foot Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nexagon® in people with Diabetic Foot Ulcer, run by OcuNexus Therapeutics, Inc. at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: For business reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and clinical effect of Nexagon® administered topically to diabetic foot ulcers.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2010.