The ASCEND Study: A Study to Investigate the Safety and Clinical Effect of Nexagon to Treat Slow Healing Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00820703
• Other study ID #: NEX-ULC-003
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: January 8, 2009
• Last updated: August 29, 2010
• Start date: April 2009
• Est. completion date: December 2009

Study information

• Verified date: August 2010
• Source: CoDa Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Medsafe
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Drug:
• Nexagon®

• Nexagon® vehicle

Locations

Country	Name	City	State
New Zealand	Middlemore Hospital	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
CoDa Therapeutics Inc.

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and clinical effect of Nexagon® administered topically to diabetic foot ulcers.
Secondary	To select the optimal dose(s) which can be used in future trials of Nexagon® in diabetic foot ulcers
Secondary	To pilot the collection of data that may be considered useful in planning future studies of Nexagon® administered topically to diabetic foot ulcers.