Clinical trial NCT01143727: Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers
Official title: Comparison of SANTYL vs. Hydrogel in Debridement of Inflamed Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Foot Ulcers
Lead sponsor: Healthpoint
Sponsor class: INDUSTRY
First posted: 2010-06-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study compares two standard methods for cleaning the surface of wounds on the feet of patients with diabetes mellitus. The question being asked is whether inflammation of the wound affects the ability of one or both of the methods to work.


Eligibility 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 the screening visit. 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.
* Of either sex, aged 18 years or older.
* A diagnosis of Diabetes Mellitus, Type I or II, requiring medication to control blood glucose levels.
* A qualifying ulcer, defined as follows:

  * Ulcer grade 1 or 2 on the Wagner Classification Scale (refer to Section 9.4.1)
  * Infection / inflammation grade 1 or 2 for wound bed inflammation (refer to Section 9.4.2)
  * Has not been treated or has not responded to treatment during the past 30 days
  * Has an apparent area ≥ 3.0 cm²
* Requires debridement of the wound bed
* Is sufficiently moist to allow collection of wound fluid using a filter paper disc
* Adequate arterial blood flow evidenced by ankle brachial index (ABI) of ≥ 0.7 and ≤ 1.1; if the ABI is greater than 1.1, then toe pressure of \>50 mmHg.
* Subject must be willing to use the Darco shoe off-loading device and insole, or a comparable device, as indicated.
* Subject able to follow instructions, particularly regarding the application of test articles and dressings at home. Able to apply the test articles, or has a caregiver available to apply the test articles according to the protocol.

Exclusion Criteria:

* Contraindications or known hypersensitivity to the test articles or their components.
* Cellulitis extending \>2 cm around the target ulcer, lymphangitic streaking, spread beneath the superficial fascia, deep-tissue abscess, gangrene, or infection of muscle, tendon, joint or bone.
* Target ulcer tunneling per probing and visual assessment.
* Use of systemic antibiotics or any drug listed in Section 9.1.6 of this protocol within 10 days of SCR visit.
* Concomitant illness or condition which, in the opinion of the Principal - Investigator, places the subject at risk for this study.
* The Medical Monitor may declare any subject ineligible for a valid procedural or medical reason.

Primary outcomes:
measure: Wound Appearance
timeFrame: 28 days
Secondary outcomes:
measure: Percent Change in Wound Area
timeFrame: 28 days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Richard C. Galperin, DPM
state: Texas
Study officials:
affiliation: Healthpoint
name: Herbert B Slade, MD
role: STUDY_CHAIR
References: