Wound Edge Changes Following Treatment With Santyl

NCT01197898 | Completed Phase 4 Results

• 1 other identifier: 017-101-09-029
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate changes in the healing tissue of diabetic foot wounds following 14 days of treatment with Santyl or its vehicle base.

Conditions

Diabetic Foot Ulcers; Diabetic Foot Wounds

Keywords

Diabetic; Foot; Ulcers; Wounds

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Extent of Presence/Absence of Epithelial Tongue.

  The results were found to be inconclusive due to the small number of biopsy specimens of sufficient quality for analysis. Four of the 10 subjects enrolled were not evaluable due to poor biopsy quality.

  28 Days

Study Arms (2)

Collagenase Santyl

EXPERIMENTAL

Ointment applied once daily

Biological: Collagenase Santyl Ointment

Vehicle Base

PLACEBO COMPARATOR

Applied once daily

Other: Placebo Comparator

Interventions

Collagenase Santyl Ointment BIOLOGICAL

Topical daily application

Collagenase Santyl

Placebo Comparator OTHER

Topical daily application

Vehicle Base

Eligibility Criteria

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

You may qualify if:

• Subjects should be presenting for the first time with a complaint of a non-healing wound, or may have failed one or more prior inadequate therapies. To improve homogeneity in the group studied, subjects with large wounds, complicated wounds, wounds of long duration, or who have failed multiple attempts at healing in which additional known critical variables were addressed (debridement, off loading, wound moisture control, wound infection control, blood glucose control, and/or adequate local blood supply) will be excluded.
• Provide written informed consent.
• Subjects 18 years of age or older, of either sex and of any race, with an existing diagnosis of Type I or Type II Diabetes Mellitus.
• Presenting for the first time with a complaint of a non-healing wound, or may have failed one or more prior inadequate therapies but not including therapies generally reserved for chronic wounds (i.e., debridement, off loading, wound moisture control, wound infection control, blood glucose control, and/or adequate local blood supply).
• Willing to attend all required study visits, and in the opinion of the Investigator, able to properly follow instructions regarding daily dressing changes (dressing changes may be done by a third party, who must agree to perform these daily).
• Body Mass Index less than or equal to 40
• A foot wound which meets the following criteria:
• Time since initial skin breakdown 56 - 112 days
• Wagner† Grade 1
• Area between 0.75 and 3.0 cm2, inclusive
• Located on plantar surface of midfoot or forefoot, dorsum of foot, or a post-amputation wound
• Non-infected based on clinical assessment
• Adequate blood supply to the affected foot, defined as meeting a transcutaneous oxygen pressure(TcPO2) measured using standard technique and within 4 cm of the wound of greater than or equal to 35 mmHg.
• Blood chemistry and hematology values as follows, using local lab normal ranges unless otherwise specified:
• Blood Glycated Hemoglobin (HbA1C) 6.5 - 10.5%

You may not qualify if:

• Subjects meeting any of the following criteria during the screening period will be excluded from the study:
• Contraindications or hypersensitivity to the use of the study medications or their components
• Therapy with another investigational agent within thirty (30) days of Visit 1.
• Calluses or maceration of periwound area which would interfere with successful biopsy of the wound edge.
• Undermining or tunneling of the target wound.
• Evidence of osteomyelitis on screening roentgenogram of the target foot.
• Coagulation defect or bleeding disorder which, in the opinion of the Investigator, will make the biopsy procedures too risky.
• The Medical Monitor may declare any subject ineligible for a valid medical reason.

Sponsors & Collaborators

• Healthpoint: lead

Study Sites (1)

Associated Foot and Ankle Specialists

Phoenix, Arizona, 85015, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Ulcer; Wounds and Injuries

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

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

jaime.dickerson@healthpoint.com

817-302-3914

Study Officials

• Herbert B Slade, MD

  Healthpoint

  STUDY CHAIR

• Art J Tallis, DPM

  Associated Foot & Ankle Specialists

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: September 9, 2010
• Study Start: December 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 30, 2013
• Results First Posted: May 30, 2013

Record last verified: 2013-04

Locations

US (1)