Using Santyl on Diabetic Foot Ulcers

NCT01408277 | Completed Phase 4 Results

• 1 other identifier: 017-101-09-030
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 7

Brief Summary

Subjects enrolled in this study will either use Santyl daily or follow standard care procedures for up to 6 weeks for their diabetic foot wound. After 6 weeks of treatment, the subjects will continue into the follow-up phase for an additional 6 weeks. Study doctors will look at the wound in the office each week (up to 12 weeks) to see if the wound is healing. Depending on a number of factors at each office visit, the study doctors may also use a procedure called sharp debridement to remove dead skin from the wound. This study will test the hypothesis that daily treatment of diabetic foot wounds with Santyl will result in more rapid healing, healthier wounds, and fewer required sharp debridements over the study period than for diabetic foot wounds treated in other ways.

Conditions

Diabetic Foot Ulcers; Diabetic Foot Wounds

Keywords

Diabetic Foot Ulcers; Diabetic Foot Wounds

Outcome Measures

Primary Outcomes (1)

• Mean Percent Change in Wound Area

  Wound area was measured using the ARANZ Silhouette digital wound imaging and measurement device. The average percent (%) of change from baseline of the target wound area at the end of the 6-week treatment period and the end of the entire 12-week study period respectively, was calculated using a two-way ANCOVA model.

  6 and 12 weeks

Study Arms (2)

Santyl

ACTIVE COMPARATOR

2mm Santyl applied once daily.

Biological: Santyl

Control

ACTIVE COMPARATOR

Standard Care

Procedure: Control

Interventions

Santyl BIOLOGICAL

2 mm Santyl applied once daily

Santyl

Control PROCEDURE

Standard Care

Also known as: Standard Care

Control

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.
• Subjects 18 years of age or older. Subjects may be 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.
• A target ulcer which is 0.5 cm2 - 10 cm2 inclusive (as measured at the Screening Visit) with a duration ≥ 30 days (documented in the patient's history or by patient report of onset) which requires sharp surgical debridement.
• Adequate arterial blood flow as evidenced by an ankle brachial index (ABI) of \> 0.7 and ≤ 1.1. If the ABI is greater than 1.1, then a toe pressure of \> 40 mmHg OR a TcPO2 ≥ 40 mmHg must be present. Either toe pressure or TcPO2 is also acceptable as a stand-alone measurement, but if both are obtained, each must meet its respective cutoff.
• Alternatively, a Doppler waveform consistent with adequate flow to the region of the foot with the target ulcer (biphasic or triphasic waveforms) is acceptable.
• A target ulcer that is not infected based on clinical assessment.
• 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.
• History of diabetes mellitus (Type 1 or 2) requiring insulin or oral hypoglycemic medications to control blood glucose levels.
• CBC and blood chemistry values as follows:
• Serum albumin ≥ 2.0 g/dL
• Pre-albumin levels of ≥ 15 mg/dL
• Alkaline phosphatase ≤ 500 U/L
• Alanine aminotransferase (ALT) ≤ 200 U/L

You may not qualify if:

• Contraindications or hypersensitivity to the use of the study medications or their components.
• Target ulcer does not require debridement.
• Uncontrolled bleeding disorder.
• Cellulitis of the target wound, 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).
• Any of the following:
• Target ulcer tunneling
• Target ulcer requires hyperbaric or negative pressure therapy per the investigator's medical judgment
• Target ulcer is on the heel and cannot be offloaded
• Target ulcer is over a Charcot deformity which cannot be offloaded
• NOTE: A heel ulcer or an ulcer over a Charcot is not excluded unless effective offloading is not possible.
• Current, ongoing osteomyelitis of the target foot as determined by medical history.
• Participation in another investigational clinical study within thirty (30) days of the Screening Visit.
• A target ulcer which involves underlying tissues (i.e., fat, fascia, tendon, muscle, bone).
• A target ulcer on a non-neuropathic foot (neuropathic defined as inability to perceive 10 grams pressure using a Semmes-Weinstein 5.07 or equivalent monofilament in the periwound area).

Sponsors & Collaborators

• Healthpoint: lead

Study Sites (7)

Associated Foot and Ankle Specialists

Phoenix, Arizona, 85015, United States

Location

Aung Foothealth Clinics

Tucson, Arizona, 85710, United States

Location

Foot Healthcare Associates, PC

Southfield, Michigan, 48076, United States

Location

Overlook Hospital Wound Care Center

Summit, New Jersey, 07901, United States

Location

UNTHSC Fort Worth

Fort Worth, Texas, 76107, United States

Location

Robert Wunderlich

San Antonio, Texas, 78212, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Motley TA, Gilligan AM, Lange DL, Waycaster CR, Dickerson JE Jr. Cost-effectiveness of clostridial collagenase ointment on wound closure in patients with diabetic foot ulcers: economic analysis of results from a multicenter, randomized, open-label trial. J Foot Ankle Res. 2015 Feb 28;8:7. doi: 10.1186/s13047-015-0065-x. eCollection 2015.

  PMID: 25767565 DERIVED

MeSH Terms

Conditions

Diabetic Foot

Interventions

Collagenases; Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Jaime E Dickerson, Jr, PhD
• Organization: Smith & Nephew Biotherapeutics

jaime.dickerson@smith-nephew.com

817-302-3914

Study Officials

• Herbert B Slade, MD

  Healthpoint

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: August 2, 2011
• First Posted: August 3, 2011
• Study Start: August 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: March 1, 2013
• Last Updated: July 24, 2014
• Results First Posted: May 5, 2014

Record last verified: 2014-06

Locations

US (7)