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Average percentage reduction in ulcer area while applying sharp debridement with or without SANTYL Ointment (2014)

On average, ulcers receiving sharp debridement demonstrated a greater reduction in ulcer area with the addition of SANTYL Ointment compared to ulcers receiving sharp debridement and typical supportive care16

Decrease in ulcer area was generally maintained through Week 12

Comparisons between groups at both Week 6 and Week 12 did not reach statistical significance

68%
from baseline
at 6 weeks

SANTYL Ointment + supportive care* + sharp debridement
(P<0.001)16†


36%
from baseline
at 6 weeks

Control group: supportive care* + sharp debridement only
(P=ns)16†‡

* Supportive care in the SANTYL Ointment group included ALLEVYN Foam Dressing, cast padding, and Coban™ bandages.

All patients agreed to wear an offloading boot or other appropriate device.

Supportive care in the control group was the clinician's choice.

Study details

Study overview, endpoints, and design

Motley TA, et al. (2014)16
Objective Exploratory study to provide descriptive data regarding the outcomes achieved after six weeks of serial sharp debridement with or without SANTYL Ointment debridement. Intent was to generate rather than test hypotheses, sample size not based on statistical power calculations
Primary endpoint Evaluate the change in ulcer area from baseline at the end of the treatment period (Week 6) and after an additional six weeks of follow-up (Week 12)
Secondary endpoint Assess wound appearance at Week 6 and Week 12 using a standardized wound assessment tool
Limitations Study was not blinded

Number of subjects

(with type 1 and 2 diabetes and non-ischemic diabetic foot ulcers)

55 patients

  • Female 26% | Male 74%
  • Mean age: 57.9
  • Race: Black 15%, white 85%
  • Ethnicity: Hispanic/Latino 16%, not Hispanic 84%
  • Mean wound area: 1.9cm2

Design

(randomized, parallel group, open-label, multicenter trials)

12-week clinical study:
Six weeks of treatment, six weeks of follow-up

Two arms:

  • SANTYL Ointment (QD) + supportive care* + periodic sharp debridement
  • Supportive care†‡ + sharp debridement

* Supportive care in the SANTYL Ointment group included ALLEVYN Foam Dressing, cast padding, and Coban™ bandages.

All patients agreed to wear an offloading boot or other appropriate device.

Supportive care in the control group was the clinician's choice.

Study results

Average percentage reduction in ulcer area from baseline16

  • The collagenase group demonstrated an average 68% reduction from baseline in ulcer area at Week 6 (P<0.001)
  • Following discontinuation of collagenase debridement at Week 6, the decrease in ulcer area was generally maintained through Week 12
  • Comparisons between groups at both Week 6 and Week 12 did not reach statistical significance due to small sample size

* Supportive care in the SANTYL Ointment group included ALLEVYN Foam Dressing, cast padding, and Coban™ bandages.

All patients agreed to wear an offloading boot or other appropriate device.

Supportive care in the control group was the clinician's choice.

Alternate Text

Log in or register to download clinical study: Outcomes of sharp debridement with or without SANTYL Ointment

What's next?

Integrating SANTYL Ointment between sharp debridements

Important Safety Information:Use of SANTYL Ointment should be terminated when debridement is complete and granulation tissue is well established.

One case of systemic hypersensitivity has been reported after 1 year of treatment with collagenase and cortisone. Occasional slight transient erythema has been noted in surrounding tissue when applied outside the wound.