Santyl Applications to Diabetic Foot Ulcers
Clinical Outcomes Associated With Enzymatic Debridement of Diabetic Foot Ulcers for Up To 12 Weeks With Clostridial Collagenase (Santyl®) Ointment
1 other identifier
interventional
215
2 countries
25
Brief Summary
The current trial examines the potential benefits of continuous 12 week treatment with Santyl, measured in terms of wound bed appearance. The visual appearance of granulation tissue will be recorded at each visit for the purpose of examining the relationship between wound bed appearance and progress towards healing. In support of this longer treatment regimen with Santyl, a recent animal study found that application of Santyl for 12 weeks was safe and well tolerated. Therefore, the present study is designed to test the hypothesis that daily treatment of diabetic foot ulcers (DFU) with Santyl for up to 12 weeks will result in more rapid development of granulation tissue than DFU treated with supportive care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2014
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 9, 2014
CompletedFirst Posted
Study publicly available on registry
April 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 17, 2016
February 1, 2016
1.7 years
April 9, 2014
February 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Well-established Granulation Tissue
12 Weeks
Secondary Outcomes (1)
Adverse Event
12 Weeks
Study Arms (2)
SANTYL®
EXPERIMENTALSupportive Care
SHAM COMPARATORInterventions
Daily application directly to the ulcer bed, approximately 2 mm thick.
Daily application of hydrogel directly to the ulcer bed (if necessary), covered with foam dressing
Eligibility Criteria
You may qualify if:
- Subjects will be considered qualified for enrollment if they meet the following criteria:
- Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information.
- Eighteen (18) years of age or older, of either sex, and of any race or skin type provided that their skin color, in the opinion of the Investigator, will not interfere with the study assessments.
- Willing and able to make all required study visits.
- Able to follow instructions and perform the dressing changes at home or have a caregiver who can perform the dressing changes according to the protocol.
- Willing to use an appropriate off-loading device whenever necessary to keep weight off of any foot ulcers.
- An ulcer present on any part of the plantar surface of the foot or plantar surface of the hallux which is 0.5 cm2 - 10 cm2 inclusive (as measured at the Screening Visit) with a duration ≥ 6 weeks but not more than 52 weeks (12 months) documented in the patient's history or by patient report of onset which requires debridement.
- Adequate arterial blood flow as evidenced by an ankle brachial index (ABI) of \> 0.70 and ≤ 1.20. If ABI \> 1.2, perfusion at or near the site of the ulcer should be confirmed; the foot is warm to the touch and has palpable pulses.
- Separation of at least 5 cm (closest ulcer edge to other closest ulcer edge) if ≥ 2 ulcers are present.
- Diabetes mellitus (Type 1 or 2) requiring insulin or oral/injectable medications to control blood glucose levels.
- Target ulcer is not infected based on clinical assessment.
You may not qualify if:
- Any one (1) of the following criteria will disqualify a potential Subject from participation in the study.
- Contraindications or hypersensitivity to the use of clostridial collagenase or hydrogel.
- Undergoing therapy with another investigational agent within thirty (30) days of Visit 1, or planned participation overlapping with this study.
- Bleeding disorder that would preclude sharp debridement during the study.
- Active cellulitis of the target ulcer, lymphangitic streaking, deep tissue abscess, gangrene, or infection of muscle, tendon, joint or bone.
- Infection with systemic toxicity or metabolic instability (e.g., fever, chills, tachycardia, hypotension, confusion, vomiting, leukocytosis, acidosis, severe hyperglycemia, azotemia).
- A target ulcer which involves the underlying tissues of tendon, muscle, or bone.
- Diagnosis of chronic granulomatous disease, leukocyte adhesion defects, or severe neutropenia.
- Current treatment (at the time of the Screening Visit) with any of the following:
- Systemic corticosteroids. If corticosteroid treatment was for ≥ 10 days, there must be a 1 week interval between discontinuation and screening.
- Immunosuppressive agents
- Chemotherapeutic agents
- Antiviral agents
- Systemic antibiotic therapy or topical antibiotic treatment of the target ulcer
- Treatment of target ulcer with bioactive therapies within 1 month of screening:
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Healthpointlead
Study Sites (25)
Unknown Facility
Mesa, Arizona, 85206, United States
Unknown Facility
Carlsbad, California, 92009, United States
Unknown Facility
Castro Valley, California, 94546, United States
Unknown Facility
Fair Oaks, California, 95628, United States
Unknown Facility
Fresno, California, 93720, United States
Unknown Facility
Sylmar, California, 91342, United States
Unknown Facility
Doral, Florida, 33178, United States
Unknown Facility
Warner Robins, Georgia, 31093, United States
Unknown Facility
Shreveport, Louisiana, 71101, United States
Unknown Facility
Baltimore, Maryland, 21215, United States
Unknown Facility
Kansas City, Missouri, 64114, United States
Unknown Facility
Las Vegas, Nevada, 89119, United States
Unknown Facility
New York, New York, 10025, United States
Unknown Facility
Greenville, North Carolina, 27834, United States
Unknown Facility
Reading, Pennsylvania, 19610, United States
Unknown Facility
York, Pennsylvania, 17402, United States
Unknown Facility
Fort Worth, Texas, 76104, United States
Unknown Facility
McAllen, Texas, 78501, United States
Unknown Facility
Temple, Texas, 76504, United States
Unknown Facility
St. George, Utah, 84770, United States
Unknown Facility
Roanoke, Virginia, 24013, United States
Unknown Facility
Virginia Beach, Virginia, 23464, United States
Unknown Facility
Calgary, Alberta, T2T 5C7, Canada
Unknown Facility
Hamilton, Ontario, L8R2R3, Canada
Unknown Facility
Montreal, Quebec, J4B 5E4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hebert B Slade, MD
Smith and Nephew Biotherapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2014
First Posted
April 11, 2014
Study Start
April 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
February 17, 2016
Record last verified: 2016-02