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2018 Motley Study Roundtable

Four experts discuss clinically meaningful results comparing SANTYL Ointment vs silver products as adjuncts to sharp debridement in diabetic foot ulcers (DFU)

Study overview

Evaluating two common adjuncts to sharp debridement in the treatment of DFUs

  • The SANTYL Ointment group demonstrated a 62% mean reduction from baseline in ulcer area at Week 6, compared to 40% in the silver treatment group (P<0.071)26
  • A secondary endpoint evaluated target ulcer infection rate based on clinical signs and symptoms of infection; all 102 study subjects were considered to be free of infection when enrolled26¶
    • During the six-week treatment period, fewer ulcer infections were observed in patients treated with SANTYL Ointment (n=5/51) than in patients treated with silver-based products (n=11/51); (P=0.208)26

Mean percent reduction in ulcer area from baseline at six weeks26

62%

SANTYL Ointment + supportive care* + periodic sharp debridement26†
n=51


(P<0.071)

40%

Silver products + supportive care§ + periodic sharp debridement26†
n=51

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

All subjects underwent sharp debridement prior to the application of the assigned test article and as medically necessary at any of the scheduled study visits.

Product containing silver was the investigator’s choice and was applied according to site procedures and the specific product’s Instructions for Use.

§ Supportive care in the control (silver) group was the clinician’s choice.

SANTYL Ointment is not indicated for the treatment or prevention of infection.

Study details

Study overview, endpoints, and design

Objective The primary objective was to compare the mean percent change in ulcer area from baseline to the end of the six-week treatment period in subjects receiving a daily application of SANTYL Ointment versus a comparator product containing silver
Primary endpoint Evaluate mean percent change in ulcer area from baseline to the end of the treatment period (Week 6) in each treatment group
Secondary endpoints
  • Incidences of target ulcer infection in each treatment group during the treatment period were based on presence of clinical signs and symptoms of infection
  • Evaluate mean percent change in ulcer area from baseline to the end of the follow-up period (Week 10)
Limitations Small sample size
Study was not blinded

Number of subjects

(with type 1 or 2 diabetes mellitus and an open neuropathic foot ulcer)

102 total patients in two equally sized groups

SANTYL Ointment group; n=51

  • Female 18% | Male 82%
  • Mean age: 56
  • Race: Alaskan native 2%, black 6%, white 92%
  • Ethnicity: Hispanic/Latino 28%, not Hispanic 72%
  • Mean wound area: 1.6cm2

Silver group; n=51

  • Female 29% | Male 71%
  • Mean age: 58
  • Race: Alaskan native 0%, black 6%, white 93%
  • Ethnicity: Hispanic/Latino 31%, not Hispanic 69%
  • Mean wound area: 1.7cm2

Design

(randomized, multicenter, parallel group study)

10-week group study:

Six weeks of treatment, four weeks of follow-up

Two arms:

  • SANTYL Ointment (QD) + supportive care* + periodic sharp debridement
  • Product containing silver + supportive care§ + periodic sharp debridement

All patients agreed to wear an appropriate offloading device.

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

All subjects underwent sharp debridement prior to the application of the assigned test article and as medically necessary at any of the scheduled study visits.

Product containing silver was the investigator’s choice and was applied according to site procedures and the specific product’s Instructions for Use.

§ Supportive care in the control (silver) group was the clinician’s choice.

Study results

Study shows SANTYL Ointment + sharp achieved clinically meaningful results vs silver + sharp26

  • The SANTYL Ointment group demonstrated a 62% mean reduction from baseline in ulcer area at Week 6, compared to 40% in the silver treatment group (P<0.071)26
  • A secondary endpoint evaluated target ulcer infection rate based on clinical signs and symptoms of infection; all 102 study subjects were considered to be free of infection when enrolled26¶
    • During the six-week treatment period, fewer ulcer infections were observed in patients treated with SANTYL Ointment (n=5/51) than in patients treated with silver-based products (n=11/51); (P=0.208)26

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

All subjects underwent sharp debridement prior to the application of the assigned test article and as medically necessary at any of the scheduled study visits.

Product containing silver was the investigator’s choice and was applied according to site procedures and the specific product’s Instructions for Use.

§ Supportive care in the control (silver) group was the clinician’s choice.

SANTYL Ointment is not indicated for the treatment or prevention of infection.

Debridement and bioburden management

Chronic wounds are typically stuck in the inflammatory phase of healing and are at a higher risk of infection.13

When infection is present in a wound, necrotic tissue must be debrided13,27

Effective debridement removes necrotic tissue, eliminating the food source for bacteria13

Infection can be a significant barrier to healing13

Necrotic tissue is the food source, or grocery store, for bacteria

“Research has demonstrated that the presence of necrotic tissue in the wound bed is associated with wound infection, and its removal works on several levels to reduce bacterial burden.”13

Complete debridement with SANTYL Ointment can positively affect bioburden26

Ongoing, daily enzymatic debridement with SANTYL Ointment can be effectively used in conjunction with treatments that address infection, including certain silver dressings, wound cleansers, and antimicrobials.21

During the six-week treatment period, fewer ulcer infections were observed in patients treated with SANTYL Ointment than in patients treated with silver-based products (P=0.208).

Secondary endpoint: Incidence of target ulcer infection based on clinical signs and symptoms of infection during the six-week treatment period*

All 102 study subjects considered free of infection at enrollment

5

SANTYL Ointment group26

n=5 out of 51


(P=0.208)

11

Silver products group26

n=11 out of 51

*SANTYL Ointment is not indicated for the treatment or prevention of infection

Log in or register to download clinical study: Mean percent reduction in ulcer area with SANTYL Ointment vs silver-based products

What's next?

Outcomes of sharp debridement with or without SANTYL Ointment

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.