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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00820703




Registration number
NCT00820703
Ethics application status
Date submitted
8/01/2009
Date registered
12/01/2009
Date last updated
31/08/2010

Titles & IDs
Public title
The ASCEND Study: A Study to Investigate the Safety and Clinical Effect of Nexagon to Treat Slow Healing Diabetic Foot Ulcers
Scientific 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
Secondary ID [1] 0 0
NEX-ULC-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Foot Ulcer 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Diabetes
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nexagon®
Treatment: Drugs - Nexagon® vehicle

Treatment: Drugs: Nexagon®


Treatment: Drugs: Nexagon® vehicle


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety and clinical effect of Nexagon® administered topically to diabetic foot ulcers.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
To select the optimal dose(s) which can be used in future trials of Nexagon® in diabetic foot ulcers
Timepoint [1] 0 0
Secondary outcome [2] 0 0
To pilot the collection of data that may be considered useful in planning future studies of Nexagon® administered topically to diabetic foot ulcers.
Timepoint [2] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 ß-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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
OcuNexus Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00820703
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00820703