Santyl vs. Sharp Debridement of Diabetic Foot Wounds

Comparison of Sharp Surgical Debridement Versus Collagenase Santyl Ointment in the Care of Diabetic Foot Wounds

This study tests two different approaches to the removal of dead tissue from the surface of a wound.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcers; Foot Wounds
• Intervention / Treatment: Drug: Santyl; Procedure: Control

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • Foot Research
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • St. Elizabeth Regional Medical Center
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Advanced Regional Center for Ankle and Foot Care
    • Langhorne, Pennsylvania, United States, 19047
      • St. Mary Medical Center
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Company, Inc.
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Research Center
    • Fort Worth, Texas, United States, 76107
      • UNTHSC Fort Worth
    • San Antonio, Texas, United States, 78212
      • Robert Wunderlich
    • Waco, Texas, United States, 76712
      • Providence Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams. In addition, the informed consent document must be signed and dated by the individual who consents the subject before conducting Visit 1. A photocopy of the signed informed consent document must be provided to the subject, and the original signed document placed in the subject's chart.
• 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.
• Willing 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 the Darco (orthopedic) shoe off-loading device and insole, if appropriate, starting on the day of screening and running through the follow-up phase.
• A history of Type I or Type II Diabetes Mellitus requiring insulin or oral hypoglycemic medications to normalize blood glucose levels.

A foot wound which is:

• Superficial, involving the full skin thickness but not underlying tissues and is 0.5 cm2 to 10 cm2 in measured surface area at screening visit (not yet debrided)
• Chronic, defined as open for 30 days
• On a neuropathic foot, defined as inability to perceive 10 grams pressure using a Semmes-Weinstein 5.07 or equivalent monofilament in the periwound area

• Adequately perfused, defined as TcPO2 > 40 mmHg; or toe pressure > 40 mmHg, or Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic waveforms) at screening.

  • Acceptable state of health and nutrition with:
• Serum albumin ≥ 2.0 g/dL (20g/L)

• Pre-albumin levels of ≥ 15 mg/dL (0.15g/L).

  • Per Screening lab chemistry† report:
• Alkaline phosphatase <500 U/L
• Alanine aminotransferase (ALT) <200 U/L
• Aspartate aminotransferase (AST) <175 U/L
• Serum total bilirubin <3.0 mg/dL
• Serum blood urea nitrogen (BUN) < 75 mg/dL
• Serum creatinine 4.5 mg/dL

• HbA1c 12%

  • Per Screening lab hematology† report:
• Hemoglobin (Hgb) > 8.0 g/dL
• White blood cells (WBC) > 2.0 109/L
• Absolute neutrophil count > 1.0 109/L

• Platelet count > 50 109/L.

  • Local laboratories will be used, but the ranges for inclusion are set based on Healthpoint Data Management ranges. Refer to Appendix 18.1.2.

Exclusion Criteria:

• Contraindications or hypersensitivity to the use of the study medications or their components (refer to product labels).
• Target wound does not require debridement, or is covered with dry eschar.
• Uncontrolled bleeding disorder.
• Untreated cellulitis extending >2 cm around the target wound, untreated lymphangitic streaking, spread beneath the superficial fascia, deep-tissue abscess, gangrene, or infection of muscle, tendon, joint or bone.
• Infection in a patient with systemic toxicity or metabolic instability (e.g., fever, chills, tachycardia, hypotension, confusion, vomiting, leukocytosis, acidosis, severe hyperglycemia, or azotemia).

• Any of the following:

  • Target wound tunneling per probing and visual assessment
  • Osteomyelitis of the target foot or wound probes to bone
  • Target wound is on the heel
  • Target wound is over a Charcot deformity which cannot be offloaded.
• Diagnosis of chronic granulomatous disease, leukocyte adhesion defects or severe neutropenia

• Treatment with any of the following:

  • Systemic corticosteroids
  • Immunosuppressive agent(s)
  • Chemotherapeutic agent(s)
  • Antiviral agent(s)
  • Platelet-derived growth factor
  • Living skin equivalent
  • Dermal substitute
  • Radiation therapy to the target lower extremity within 30 days prior to signing the informed consent document.
  • Currently on systemic antibiotic therapy
• Any medical condition judged by the Medical Monitor and/or Investigator to cause the study to be detrimental to the subject (specify on the reason for screen failure if this applies).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Santyl; 2 mm Santyl applied once daily	Drug: Santyl; 2 mm Santyl applied once daily.
Sham Comparator: Control; Daily gauze and optional sharp debridement	Procedure: Control; Daily gauze and optional sharp debridement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bates-Jensen Wound Assessment Score - Modified (BWAT-m)	The Bates-Jensen Wound Assessment Score was used to collect information about the wound bed appearance in each of 8 categories (sub-scales) each with a possible score of 1 to 5. For each sub-scale intact skin was scored a one (1) while a five (5) would indicate the worst possible rating. All scores were combined to compute a total score for each arm/group, with a score of 8 indicating intact skin (minimum summed score), and a score of 40 indicating the worst possible rating (maximum summed score).	baseline and 28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent of Wound Area Change From Baseline at End of Treatment	baseline and 28 days
Percent of Wound Area Change From Baseline at the End of 12 Week Follow-up	baseline and 84 days

Collaborators and Investigators

• Sponsor: Healthpoint
• Investigators: Study Chair: Herbert B Slade, MD, Healthpoint, Ltd.; Study Director: Herbert B Slade, MD, Healthpoint, Ltd

Publications and helpful links

General Publications

• Tallis A, Motley TA, Wunderlich RP, Dickerson JE Jr, Waycaster C, Slade HB; Collagenase Diabetic Foot Ulcer Study Group. Clinical and economic assessment of diabetic foot ulcer debridement with collagenase: results of a randomized controlled study. Clin Ther. 2013 Nov;35(11):1805-20. doi: 10.1016/j.clinthera.2013.09.013. Epub 2013 Oct 18.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: January 25, 2010
• First Submitted That Met QC Criteria: January 25, 2010
• First Posted (Estimate): January 26, 2010

Study Record Updates

• Last Update Posted (Estimate): November 21, 2012
• Last Update Submitted That Met QC Criteria: October 23, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Diabetic Foot Ulcers; Diabetic Foot Wounds
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Wounds and Injuries
• Other Study ID Numbers: 017-101-09-028