Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use

Diabetic Foot Ulcer Clinical Trial

— STRIDE 5  

Official title:

Open-Label Phase III Clinical Trial to Evaluate the Safety of 0.03% DSC127 Gel in Chronic Use for Treating Diabetic Foot Ulcers ("DFU")

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01840085
• Other study ID #: DSC127-2012-05
• Status: Terminated
• Phase: Phase 3
• First received: April 23, 2013
• Last updated: December 8, 2017
• Start date: December 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2017
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety of topical 0.03% DSC127 Gel when used for one or more continuous treatment periods on a chronic Wagner Grade 1 or 2 foot ulcer(target ulcer) or multiple ulcers in diabetic subjects. The maximum duration of any treatment period is 24 weeks.

Description:

All eligible subjects enrolled will begin daily Treatment with topical 0.03% DSC127 gel until complete wound closure (defined as skin re-epithelialization without drainage or dressing requirement) or 24 weeks, whichever occurs first.

If a patient has multiple ulcers on one foot, all may be treated, within the maximum of 24 weeks. If the ulcer does not heal, after a wash out period of 1 week, a new treatment period of up to 24 weeks may be initiated. Ulcer may be retreated if it recurs or if a new ulcer develops that meets study criteria.

For the entire duration of each treatment period the standard of care for DFU will be maintained.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 261
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female ambulatory subjects who are at least 18 years of age at screening

2. Have at least one ulcer:

1. chronic ( present >1month)

2. Wagner Grade 1 or Grade 2 ulcer (i.e. Partial- or full- thickness and not involving bone, tendon or capsule (probing to tendon or capsule) and/or penetrating to tendon or capsule.)

3. with no sign of infection or osteomyelitis, and

4. is located below the malleolus.

3. Have an ABI > 0.7, or have a TcPO2 > 40 mm Hg or great toe systolic pressure > 50 mmHg to ensure healing potential.

4. Have Type I or Type II diabetes under metabolic control as confirmed by glycosylated hemoglobin (HbA1c) of = 14%, obtained at enrollment or within 30 days prior to study enrollment.

5. Female subjects of child-bearing potential must have a negative pregnancy test at the time of enrollment and at the initiation of each study treatment period.

6. Female subjects of child-bearing potential must be willing to use a medically acceptable method of birth control, such as Essure®, hormonal contraception (oral pills, implantable device or skin patch), intrauterine device, tubal ligation, double barrier, or abstinence during the treatment periods of study participation.

7. Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study or initiation of study procedures

Exclusion Criteria:

1. Has a known hypersensitivity to any of the study medication components.

2. Exposure to any investigational product within 30 days of entry into study.

3. Has active malignant disease of any kind (with the exception of basal cell carcinoma). A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry. Disease-free is defined as in remission for at least 5 years.

4. Chronic liver dysfunction evidenced by transaminase levels > 2.5 times higher than the upper level of normal on two occasions.

5. Has a history of additional risk factors for TdP (eg. heart failure, hypokalemia, family history of Long QT Syndrome) or taking medication which are known to prolong QT/QTc (Appendix G)

6. Receiving hemodialysis or chronic ambulatory peritoneal dialysis (CAPD) therapy.

7. Prior radiation therapy of the foot with the ulcer under study.

8. Current use of systemic corticosteroids or immunosuppressants within 8 weeks prior to enrollment into the study

9. Sickle-cell anemia, Raynaud's or other peripheral vascular disease.

10. Subjects receiving a biologic agent to include growth factors and skin equivalents (Regranex, Apligraft, or Dermagraft) in the 7 days prior to exposure to DSC127.

11. Subject who, in the opinion of the investigator, has uncontrolled hypertension

12. Subject has an ulcer which is determined to be clinically infected and requires antimicrobials or agents known to affect wound healing or has been taking systemic antibiotics for more than 7 days for any reason. (Subjects with infection at the initial visit of the Screening Period can be re-screened three weeks later after a single course of antibiotic therapy (occurring concurrently - within three weeks of the initial visit, the antibiotic treatment must have completed and some washout (7 days) must have elapsed); if after that time infection is still present, the subject will be excluded.)

13. Subjects who, in the opinion of the investigator, have clinically significant anemia

Related Conditions & MeSH terms

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

Intervention

Drug:
• 0.03% DSC127 topical gel

Locations

Country	Name	City	State
United States	Carolina Musculoskeletal Institute	Aiken	South Carolina
United States	Reliance Institute of Clinical Research	Chino	California
United States	Limb Preservation Platform (LPP)	Fresno	California
United States	Roy O. Kroeker, DMP, Inc.	Fresno	California
United States	Eastern Carolina Foot & Ankle Specialists	Greenville	North Carolina
United States	Advanced Research Institute of Miami	Homestead	Florida
United States	UF Health Orthopaedic Surgery Clinic	Jacksonville	Florida
United States	Foot and Ankle Clinic	Los Angeles	California
United States	Miami Dade Medical Research Institute	Miami	Florida
United States	Phoenix Medical Research, LLC	Miami	Florida
United States	GF Professional Research	Miami Lakes	Florida
United States	WILMAX Clinical Research	Mobile	Alabama
United States	Barry University Clinical Research	North Miami Beach	Florida
United States	Professional Education and Research Institute	Roanoke	Virginia
United States	Professional Health Care of Pinellas	Saint Petersburg	Florida
United States	Endeavor Clinical Trials	San Antonio	Texas
United States	Center for Clinical Research, Inc.	San Francisco	California
United States	Olive View - UCLA Medical Center	Sylmar	California
United States	Orange County Research Center	Tustin	California
United States	O'Malley Foot and Ankle	Wilmington	North Carolina
United States	Martin Foot & Ankle	York	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation	Integrium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes from baseline in laboratory evaluations (clinically significant changes)		2.5yrs
Other	Proportion of all subjects treated and terminating prematurely due to adverse events related to study treatment.		2.5yrs
Primary	The proportion of all subjects reporting Adverse Events and Serious Adverse Events related to study treatment		2.5yrs