Santyl vs. Sharp Debridement of Diabetic Foot Wounds

NCT01056198 | Completed Phase 4 Results

• 1 other identifier: 017-101-09-028
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Diabetic Foot Ulcers; Foot Wounds

Keywords

Diabetic Foot Ulcers; Diabetic Foot Wounds

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Santyl

ACTIVE COMPARATOR

2 mm Santyl applied once daily

Drug: Santyl

Control

SHAM COMPARATOR

Daily gauze and optional sharp debridement

Procedure: Control

Interventions

Santyl DRUG

2 mm Santyl applied once daily.

Santyl

Control PROCEDURE

Daily gauze and optional sharp debridement

Control

Eligibility Criteria

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

You may qualify if:

• 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:

You may not qualify if:

• 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)

Sponsors & Collaborators

• Healthpoint: lead

Study Sites (9)

Foot Research

Phoenix, Arizona, 85015, United States

Location

St. Elizabeth Regional Medical Center

Lincoln, Nebraska, 68510, United States

Location

Advanced Regional Center for Ankle and Foot Care

Altoona, Pennsylvania, 16602, United States

Location

St. Mary Medical Center

Langhorne, Pennsylvania, 19047, United States

Location

Paddington Testing Company, Inc.

Philadelphia, Pennsylvania, 19103, United States

Location

Arlington Research Center

Arlington, Texas, 76011, United States

Location

UNTHSC Fort Worth

Fort Worth, Texas, 76107, United States

Location

Robert Wunderlich

San Antonio, Texas, 78212, United States

Location

Providence Health Center

Waco, Texas, 76712, United States

Location

Related Publications (1)

• 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.

  PMID: 24145042 DERIVED

MeSH Terms

Conditions

Diabetic Foot

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; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jaime E. Dickerson, PhD; Sr. Director Clinical Affairs
• Organization: Healthpoint Biotherapeutics

jaime.dickerson@healthpoint.com

817-302-3914

Study Officials

• Herbert B Slade, MD

  Healthpoint, Ltd.

  STUDY CHAIR

• Herbert B Slade, MD

  Healthpoint, Ltd

  STUDY DIRECTOR

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: January 25, 2010
• First Posted: January 26, 2010
• Study Start: February 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 21, 2012
• Results First Posted: November 21, 2012

Record last verified: 2012-10

Locations

US (9)