Santyl vs. Sharp Debridement of Diabetic Foot Wounds

Diabetic Foot Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056198
• Other study ID #: 017-101-09-028
• Status: Completed
• Phase: Phase 4
• First received: January 25, 2010
• Last updated: October 23, 2012
• Start date: February 2010
• Est. completion date: November 2011

Study information

• Verified date: October 2012
• Source: Healthpoint
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Foot Wounds

Intervention

Drug:
• Santyl
2 mm Santyl applied once daily.

Procedure:
• Control
Daily gauze and optional sharp debridement

Locations

Country	Name	City	State
United States	Advanced Regional Center for Ankle and Foot Care	Altoona	Pennsylvania
United States	Arlington Research Center	Arlington	Texas
United States	UNTHSC Fort Worth	Fort Worth	Texas
United States	St. Mary Medical Center	Langhorne	Pennsylvania
United States	St. Elizabeth Regional Medical Center	Lincoln	Nebraska
United States	Paddington Testing Company, Inc.	Philadelphia	Pennsylvania
United States	Foot Research	Phoenix	Arizona
United States	Robert Wunderlich	San Antonio	Texas
United States	Providence Health Center	Waco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Healthpoint

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percent of Wound Area Change From Baseline at End of Treatment		baseline and 28 days	No
Secondary	Percent of Wound Area Change From Baseline at the End of 12 Week Follow-up		baseline and 84 days	No