Use of Santyl in Diabetic Foot Ulcers

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02581488
• Date of registration: 19/10/2015
• Prospective Registration: No
• Primary sponsor: Smith & Nephew, Inc.
• Public title: Use of Santyl in Diabetic Foot Ulcers
• Scientific title: Clinical Outcomes for Diabetic Foot Ulcers Treated With Clostridial Collagenase (SANTYL®) Ointment or With a Comparator Product Containing Silver
• Date of first enrolment: October 2015
• Target sample size: 102
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02581488
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Canada, United States

Contacts

• Name: Robert Eichelkraut
• Affiliation: Smith & Nephew, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

1. 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.

2. Eighteen (18) years of age or older, of either sex, and of any race or skin type.

3. Willing and able to make all required study visits.

4. 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.

5. Willing to use an appropriate off-loading device to keep weight off of foot ulcers.

6. An ulcer present on any part of the plantar surface of the neuropathic foot or hallux
which is 0.5 cm2 - 10 cm2 inclusive (as measured at the Screening Visit using the
ARANZ Silhouette imaging device). The target ulcer duration must be = 6 weeks but not
more than 52 weeks (12 months) as documented in the subject's history or by subject
report of onset, and which requires debridement.

7. 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.

8. Separation of at least 5 cm (closest ulcer edge to other closest ulcer edge) if = 2
ulcers are present as measured using the ARANZ Silhouette imaging device.

9. Diabetes mellitus (Type 1 or 2) requiring insulin or oral/injectable medications to
control blood glucose levels.

10. Target ulcer is not infected based on clinical assessment.

Exclusion Criteria:

1. Contraindications or hypersensitivity to the use of clostridial collagenase or
products containing silver.

2. Participation in another clinical trial within thirty (30) days of Visit 1, or planned
participation overlapping with this study.

3. Bleeding disorder that would preclude sharp debridement during the study.

4. Active cellulitis of the target ulcer, lymphangitic streaking, deep tissue abscess,
gangrene, or infection of muscle, tendon, joint or bone.

5. Infection with systemic toxicity or metabolic instability (e.g., fever, chills,
tachycardia, hypotension, confusion, vomiting, leukocytosis, acidosis, severe
hyperglycemia, azotemia).

6. A target ulcer which involves the underlying tissues of tendon, muscle, or bone.

7. Diagnosis of chronic granulomatous disease, leukocyte adhesion defects, or severe
neutropenia.

8. 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 (for any reason) or topical antibiotic treatment of
the target ulcer

9. Treatment of target ulcer with bioactive therapies within 1 month of screening:

- Platelet-derived growth factor (e.g., Regranex®)

- Living skin equivalent (e.g., Apligraf®)

- Dermal substitute (e.g., Dermagraft®, Integra®, Oasis®, etc.)

- Amniotic membrane products (e.g., EpiFix®, Grafix®, etc.)

10. Prior treatment of target ulcer for any length of time with clostridial collagenase
ointment (SANTYL®).

11. Radiation therapy to the target lower extremity within 30 days prior to screening.

12. Medical or physical condition that, in the opinion of the Investigator, would preclude
safe subject participation in the study.

13. Blood counts and blood chemistry values as follows:

- Alanine aminotransferase (ALT) > 3x upper limit of normal

- Aspartate aminotransferase (AST) > 3x upper limit of normal

- Gamma Glutamyl Transferase (GGT) > 2.5x upper limit of normal

- Serum albumin < 2.0 g/dL • Pre-albumin levels of < 10 mg/dL

- Alkaline phosphatase > 500 U/L • Serum total bilirubin > 3.0 mg/dL

- Serum BUN > 75 mg/dL • Serum creatinine > 4.5 mg/dL

- HbA1c > 12% • Hemoglobin (Hgb) < 8.0 g/dL

- WBC < 2.0 x 109/L • Absolute neutrophil count < 1.0 x 109/L

- Platelet count < 50 x 109/L



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetic Foot

Foot Ulcer, Diabetic

Intervention(s)

Other: Product containing silver

Biological: Santyl

Primary Outcome(s)

Mean Percent Change in Ulcer Area From Baseline to the End of the Treatment. [Time Frame: 6 weeks]

Secondary Outcome(s)

Target Ulcer Infection Rates in Each Treatment Group During the Treatment Period as Determined by Investigator-reported Adverse Events [Time Frame: 6 weeks]

Secondary ID(s)

017-101-09-035

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 01/08/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02581488