Phase III Study to Evaluate Efficacy and Safety of DSC127 in Diabetic Foot Ulcers

Diabetic Foot Ulcers Clinical Trial

— STRIDE 1  

Official title:

A Randomized, Double-blind, Parallel-group, Vehicle-controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DSC127 in Treating Non-healing Foot Ulcers in Subjects With Diabetes Mellitus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01830348
• Other study ID #: DSC127-2012-01
• Status: Terminated
• Phase: Phase 3
• First received: March 15, 2013
• Last updated: December 8, 2017
• Start date: February 2013
• 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

The purpose of the study is to determine if DSC127 is effective in increasing incidence of complete wound closure at 10 weeks confirmed at a visit 2 weeks later when compared to the vehicle (gel without active ingredient) in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 plantar neuropathic foot ulcers, 0.75 - 6 cm2 in size.

Description:

Subjects will undergo a two week screening period to assess plantar ulcer healing, and those healing less than 30% will be eligible for randomization, providing they meet all other inclusion criteria. Four weeks of blinded "treatment" follows the screening period, and an observation period of six weeks (to 10 weeks post first treatment) follows the 4-week treatment period. If the ulcer closes during the treatment or observation period, the closure will be confirmed two weeks later, and at this time the subject enters a durability assessment period of up to 12 weeks.

All aspects of Standard of Care are followed throughout the study period.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 266
• 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 subject age =18 years at the time of informed consent

2. Has type 1 or type 2 DM under metabolic control as confirmed by a glycosylated hemoglobin (HbA1c) of =12% and a serum creatinine level of =3mg/dL

3. At Screening and at Baseline (prior to randomization), subject has at least one ulcer that fulfills all of the following criteria:

• Present for =1 month and =1 year

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

• Has no sign of infection or osteomyelitis

• Plantar neuropathic ulcer; ulcer must be predominantly on the plantar surface of the foot to ensure adequate off-loading and may include the toes

• Size of the target ulcer must be 0.75 - 6 cm2

• Target ulcer must be non-healing as defined as <30% reduction in size in response to standard of care during the two week Screening Period

• If more than one ulcer is present that meets the inclusion criteria, the largest one will be considered the Target ulcer.

• If there are two ulcers of the same size that meet all criteria, the one with the higher Wagner Grade will be considered the Target ulcer.

• If there are two ulcers of the same size and the same Wagner Grade, the one present for the longest qualifying time will be the Target ulcer.

4. Has an ankle brachial index (ABI) = 0.7 on the foot with the target ulcer

5. Has an assessment of the baseline level of neuropathy of the foot using Semmes-Weinstein filaments.

6. A female subject of childbearing potential must have a negative serum pregnancy test at the time of Screening, and 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, or double barrier throughout the study. A female subject of childbearing potential who practices abstinence is not required to employ birth control.

7. Has the 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 investigational drug or vehicle components

2. Has been exposed to any investigational agent within 30 days of entry into the study

3. A female who is pregnant or nursing

4. Has active malignant disease of any kind except for basal cell carcinoma (of the skin). A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry.

5. Has a hemoglobin of less than 8.5 gm/dL.

6. Transaminase levels greater than 3 × normal

7. Is receiving hemodialysis or chronic ambulatory peritoneal dialysis (CAPD) therapy

8. Has had prior radiation therapy of any part of the foot with the target ulcer under study

9. Use of systemic corticosteroids and immunosuppressants (within the 8 weeks prior to screening)

10. Has an ulcer primarily ischemic in etiology

11. Has sickle-cell anemia, Reynaud's, or other peripheral vascular disease

12. Has received a biologic agent, growth factors or skin equivalents (Regranex®, Apligraft, or Dermagraft), in the past 30 days

13. Has a target ulcer which is determined to be clinically infected and requires antimicrobials. Any antibiotic therapy must be completed or discontinued at screening.

14. Has a Wagner Grade 3 or greater DFU, deep abscess, or gangrene

15. Has uncontrolled hypertension, in the opinion of the Investigator.

16. Any other finding, which in the opinion of the Investigator, may interfere with the assessment of the product or participation of the subject in the study.

Related Conditions & MeSH terms

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

Intervention

Drug:
• DSC127
DSC127 0.03%, daily topical application to diabetic foot ulcer for a period of up to 28 days or until ulcer closure, whichever is sooner
• placebo vehicle gel

Locations

Country	Name	City	State
United States	Carolina Musculoskeletel Institute	Aiken	South Carolina
United States	Boston University Medical Center	Boston	Massachusetts
United States	ClinSearch, LLC	Chattanooga	Tennessee
United States	Dallas VA Medical Center	Dallas	Texas
United States	Clinical Research Center	Eugene	Oregon
United States	Center for Clinical Research	Fair Oaks	California
United States	Fort Worth Diagnostic Clinic	Fort Worth	Texas
United States	Roy O Kroeker, DPM, Inc	Fresno	California
United States	Memorial Medical Group	Granger	Indiana
United States	East Carolina Foot and 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	LaPorte Medical Group	LaPorte	Indiana
United States	Foot and Ankle Clinic	Los Angeles	California
United States	Miami Dade Medical Research Institute	Miami	Florida
United States	GF Professional Research	Miami Lakes	Florida
United States	WILMAX Clinical Research Inc	Mobile	Alabama
United States	Barry University Clinical Research	North Miami Beach	Florida
United States	Brian O'Carroll, DPM, Inc.	Pismo Beach	California
United States	Center for Clinical Research	Portland	Oregon
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	UCLA Medical Center - Olive View	Sylmar	California
United States	Orange County Research Center	Tustin	California

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	Percent reduction in ulcer area per week (closure rate)	Calculated weekly for up to ten weeks	Weekly ulcer tracings to calculate area of ulcer, measurements continue to ten weeks post first treatment dose
Other	Incidence of target ulcer recurrence, time to ulcer recurrence, and number of days target ulcer remains closed after confirmed complete wound closure has been established.		Assessed during a 12 week durability period following the confirmation of complete wound closure
Primary	The proportion of subjects with a target ulcer which achieves complete wound closure (skin re-epithelialization without drainage or dressing requirements) up to 10 weeks (confirmed at a study visit 2 weeks later).	Primary endpoint of complete closure is assessed by the Principal Investigator at the site; ulcer measurements are calculated through tracings submitted to the Canfield system and photographs are collected as confirmation of closure via the Canfield system.	Target ulcer must achieve complete wound closure by 10 weeks post first treatment
Secondary	Time to the visit where the target ulcer achieves confirmed complete wound closure		Weekly assessments to ten weeks post first treatment dose