Use of Santyl in Diabetic Foot Ulcers

NCT02581488 | Completed Phase 4 Results

• 1 other identifier: 017-101-09-035
• Study Type: interventional
• Target: 102
• Locations: 2 countries
• Sites: 13

Brief Summary

This study is designed to test the hypothesis that daily treatment of diabetic foot ulcers with an enzymatic debriding agent, SANTYL, for up to 6 weeks will result in more rapid decrease in ulcer area than diabetic foot ulcers treated with a topical treatment containing silver. After meeting study criteria, participants will be randomly assigned to apply SANTYL or a topical treatment containing silver to their to foot ulcer for up to 6 weeks. At the end of 6 weeks, participants will be followed for an additional 4 weeks to examine the outcome of the study treatment.

Conditions

Diabetic Foot; Foot Ulcer, Diabetic

Keywords

Diabetes; diabetic foot ulcer; foot sore; type 2 diabetes; type 1 diabetes; neuropathy; DFU

Outcome Measures

Primary Outcomes (1)

• Mean Percent Change in Ulcer Area From Baseline to the End of the Treatment.

  Ulcer area was measured using the ARANZ Silhouette digital imaging and measurement device.

  6 weeks

Secondary Outcomes (1)

• Target Ulcer Infection Rates in Each Treatment Group During the Treatment Period as Determined by Investigator-reported Adverse Events

  6 weeks

Other Outcomes (2)

• Time to Closure for Ulcers Achieving Closure in Treatment Period

  6 weeks

• Time to Closure for Ulcers Achieving Closure by End of Follow-up

  10 weeks

Study Arms (2)

Santyl

EXPERIMENTAL

Collagenase ointment applied topically once per day for up to six weeks.

Biological: Santyl

Product containing silver

ACTIVE COMPARATOR

Products containing silver will be applied per Investigator instructions and instructions for use/package insert for up to six weeks.

Other: Product containing silver

Interventions

Santyl BIOLOGICAL

Santyl

Product containing silver OTHER

Silver product not specified by the protocol; Investigators choose the appropriate silver containing product for each diabetic foot ulcer

Product containing silver

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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 to keep weight off of foot ulcers.
• 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.
• 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 as measured using the ARANZ Silhouette imaging device.
• 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:

• Contraindications or hypersensitivity to the use of clostridial collagenase or products containing silver.
• Participation in another clinical trial 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 (for any reason) or topical antibiotic treatment of the target ulcer
• Treatment of target ulcer with bioactive therapies within 1 month of screening:
• Platelet-derived growth factor (e.g., Regranex®)

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (13)

Unknown Facility

Sylmar, California, 91342, United States

Location

Unknown Facility

Melbourne, Florida, 32935, United States

Location

Unknown Facility

Baltimore, Maryland, 21215, United States

Location

Unknown Facility

Las Vegas, Nevada, 89119, United States

Location

Unknown Facility

York, Pennsylvania, 17402, United States

Location

Unknown Facility

Fort Worth, Texas, 76107, United States

Location

Unknown Facility

McAllen, Texas, 78501, United States

Location

Unknown Facility

St. George, Utah, 84770, United States

Location

Unknown Facility

Harrisonburg, Virginia, 22801, United States

Location

Unknown Facility

Roanoke, Virginia, 24013, United States

Location

Unknown Facility

Virginia Beach, Virginia, 23464, United States

Location

Unknown Facility

Hamilton, Ontario, L8R 2R3, Canada

Location

Unknown Facility

Boucherville, Quebec, J4B 5E4, Canada

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Interventions

Collagenases

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Results Point of Contact

• Title: SR. Clinical Study Manager, US Global Clinical Operations
• Organization: Smith and Nephew

Darrell.Lange@smith-nephew.com

+1 817-302-3959

Study Officials

• Robert Eichelkraut

  Smith & Nephew, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: October 19, 2015
• First Posted: October 21, 2015
• Study Start: October 1, 2015
• Primary Completion: January 12, 2017
• Study Completion: January 12, 2017
• Last Updated: August 1, 2018
• Results First Posted: August 1, 2018

Record last verified: 2018-05

Locations

US (11); CA (2)