Santyl vs. Sharp Debridement of Diabetic Foot Wounds

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT01056198
First received: January 25, 2010
Last updated: October 23, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
Diabetic Foot Ulcers
Foot Wounds
Drug: Santyl
Procedure: Control
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Sharp Surgical Debridement Versus Collagenase Santyl Ointment in the Care of Diabetic Foot Wounds

Resource links provided by NLM:


Further study details as provided by Healthpoint:

Primary Outcome Measures:
  • Bates-Jensen Wound Assessment Score - Modified (BWAT-m) [ Time Frame: baseline and 28 days ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Percent of Wound Area Change From Baseline at End of Treatment [ Time Frame: baseline and 28 days ] [ Designated as safety issue: No ]
  • Percent of Wound Area Change From Baseline at the End of 12 Week Follow-up [ Time Frame: baseline and 84 days ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: February 2010
Study Completion Date: November 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056198

Locations
United States, Arizona
Foot Research
Phoenix, Arizona, United States, 85015
United States, Nebraska
St. Elizabeth Regional Medical Center
Lincoln, Nebraska, United States, 68510
United States, Pennsylvania
Advanced Regional Center for Ankle and Foot Care
Altoona, Pennsylvania, United States, 16602
St. Mary Medical Center
Langhorne, Pennsylvania, United States, 19047
Paddington Testing Company, Inc.
Philadelphia, Pennsylvania, United States, 19103
United States, Texas
Arlington Research Center
Arlington, Texas, United States, 76011
UNTHSC Fort Worth
Fort Worth, Texas, United States, 76107
Robert Wunderlich
San Antonio, Texas, United States, 78212
Providence Health Center
Waco, Texas, United States, 76712
Sponsors and Collaborators
Healthpoint
Investigators
Study Chair: Herbert B Slade, MD Healthpoint, Ltd.
Study Director: Herbert B Slade, MD Healthpoint, Ltd
  More Information

No publications provided by Healthpoint

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01056198     History of Changes
Other Study ID Numbers: 017-101-09-028
Study First Received: January 25, 2010
Results First Received: March 15, 2012
Last Updated: October 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Healthpoint:
Diabetic Foot Ulcers
Diabetic Foot Wounds

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on August 19, 2014