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Mean percent reduction in ulcer area when integrating SANTYL Ointment between sharp debridements (2017)

Patients treated with enzymatic debridement (SANTYL Ointment) experienced fewer stalled wounds17

Those who switched to SANTYL Ointment were 4x as likely to achieve closure by Week 12. 33% (n=12) of hydrogel-to-SANTYL Ointment patients vs 8% (n=12) of SANTYL Ointment-to-hydrogel patients (P=ns)17

A separate study demonstrated that ulcers that don’t achieve 53% decrease in size by Week 4 have only a 9% chance of healing at 12 weeks18

65%
from baseline
at 12 weeks

SANTYL Ointment + supportive care* + sharp debridement
(P<0.0001)17


51%
from baseline
at 12 weeks

Control group: hydrogel + supportive care* + sharp debridement
(P=0.0001)17

* Supportive care: ulcers covered with daily foam dressings in both study arms

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

Study details

Study overview, endpoints, and design

Jimenez JC, et al. (2017)17
Objective Evaluate the clinical outcomes associated with the use of clostridial collagenase ointment + supportive care* + sharp debridement compared with hydrogel + supportive care* + sharp debridement
Primary endpoint Evaluate the percent change in ulcer area after six weeks of treatment and again at 12 weeks
Secondary endpoint Evaluate the effect of baseline wound microbiota on subsequent healing
Limitations Study was not blinded

Number of subjects

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

215 patients

  • Female 20% | Male 80%
  • Mean age: 57.1
  • Race: Black 16%, white 79%, Asian 1%, other 3%
  • Ethnicity: Hispanic/Latino 21%, not Hispanic 79%
  • Mean wound area: 1.6cm2

Design

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

12-week clinical trial:
12 weeks of treatment

Two arms:

  • SANTYL Ointment (QD) + supportive care* + sharp debridement
  • A hydrogel (QD) + supportive care* + sharp debridement

* Supportive care: ulcers covered with daily foam dressings in both study arms

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

Study results

Mean percent reduction in ulcer area from baseline17

  • The collagenase group demonstrated a mean percent reduction in ulcer area from baseline of 65% (P<0.0001) at the end of the 12-week treatment phase compared to a 51% (P=0.0001) reduction in the hydrogel group
  • Reductions in ulcer area from baseline were statistically significant within the collagenase group after one week of treatment (P<0.0001)
  • Mean percent reductions for collagenase were greater than for hydrogel at each of the 12 study assessment points. Comparisons between groups did not reach statistical significance
  • Bacterial load was found to have a negative effect on wound closure in the SANTYL Ointment group (r=-0.053) and hydrogel group (r=-0.15)
Alternate Text

* Supportive care: all ulcers were covered with a non-adherent foam dressing, changed daily, and given sharp debridement when medically warranted.

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

Applied daily to maintain moist environment.

SANTYL Ointment helped advance stalled wounds17

Twelve patients from each group who showed no improvement in wound progression at Week 4 were crossed-over to the opposite treatment group.

Patients who switched to SANTYL Ointment were 4x more likely to achieve closure by Week 12 (33% vs 8%) when compared to those who were switched to supportive care (P=ns)17

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What's next?

Efficacy comparison to wet-to-dry + sharp

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.