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Trial record 1 of 1 for:    NCT01408277
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Using Santyl on Diabetic Foot Ulcers

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ClinicalTrials.gov Identifier: NCT01408277
Recruitment Status : Completed
First Posted : August 3, 2011
Results First Posted : May 5, 2014
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
Healthpoint

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetic Foot Ulcers
Diabetic Foot Wounds
Interventions Biological: Santyl
Procedure: Control
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Santyl Control
Hide Arm/Group Description Collagenase (SANTYL®) Ointment Standard Care
Period Title: Overall Study
Started 28 27
Completed 20 23
Not Completed 8 4
Reason Not Completed
Adverse Event             3             4
Lost to Follow-up             1             0
Withdrawal by Subject             2             0
Protocol Violation             2             0
Arm/Group Title Santyl Control Total
Hide Arm/Group Description Collagenase (SANTYL®) Ointment Standard Care Total of all reporting groups
Overall Number of Baseline Participants 28 27 55
Hide Baseline Analysis Population Description
20 subjects from each group was a priori considered to be a number sufficient to detect an effect size (Cohen’s d) of 0.80, regarded as a large effect, with α = 0.05 and 1-β = 80%.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 27 participants 55 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
  78.6%
20
  74.1%
42
  76.4%
>=65 years
6
  21.4%
7
  25.9%
13
  23.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 27 participants 55 participants
Female
7
  25.0%
7
  25.9%
14
  25.5%
Male
21
  75.0%
20
  74.1%
41
  74.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 27 participants 55 participants
Hispanic or Latino
5
  17.9%
4
  14.8%
9
  16.4%
Not Hispanic or Latino
23
  82.1%
23
  85.2%
46
  83.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 27 participants 55 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  10.7%
5
  18.5%
8
  14.5%
White
25
  89.3%
22
  81.5%
47
  85.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 27 participants 55 participants
28 27 55
1.Primary Outcome
Title Mean Percent Change in Wound Area
Hide Description Wound area was measured using the ARANZ Silhouette digital wound imaging and measurement device. The average percent (%) of change from baseline of the target wound area at the end of the 6-week treatment period and the end of the entire 12-week study period respectively, was calculated using a two-way ANCOVA model.
Time Frame 6 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Primary analysis was based on the Intent-to-treat dataset which consisted of all subjects randomized to treatment.
Arm/Group Title Santyl® Control
Hide Arm/Group Description:
Collagenase (Santyl®) Ointment

Control = Standard Care

Standard Care is defined as the standard wound care protocol for chronic wounds used by each Investigator, in their clinic (e.g., wet-to-dry, compression, sharp debridement, etc.).

Overall Number of Participants Analyzed 28 27
Mean (Standard Error)
Unit of Measure: percentage of change in wound area
% change at end of 6 weeks -68  (6.3) -36  (20.4)
% change at end of 12 weeks -61  (9.6) -46  (18.3)
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Santyl Control
Hide Arm/Group Description Collagense (Santyl®) Ointment Standard Care
All-Cause Mortality
Santyl Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Santyl Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/28 (10.71%)      4/27 (14.81%)    
Cardiac disorders     
Atrial fibrillation  1  0/28 (0.00%)  0 1/27 (3.70%)  1
Infections and infestations     
Cellulitis  1  1/28 (3.57%)  1 1/27 (3.70%)  1
Gangrene  1  1/28 (3.57%)  1 0/27 (0.00%)  0
Osteomyelitis  1  1/28 (3.57%)  1 2/27 (7.41%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Santyl Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/28 (25.00%)      6/27 (22.22%)    
Infections and infestations     
Cellulitis  1  2/28 (7.14%)  2 2/27 (7.41%)  2
Osteomyelitis  1  1/28 (3.57%)  1 2/27 (7.41%)  2
Upper respiratory tract infection  1  0/28 (0.00%)  0 2/27 (7.41%)  2
Injury, poisoning and procedural complications     
Wound complication  1  2/28 (7.14%)  2 0/27 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Neuropathic arthropathy  1  2/28 (7.14%)  2 0/27 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jaime E Dickerson, Jr, PhD
Organization: Smith & Nephew Biotherapeutics
Phone: 817-302-3914
EMail: jaime.dickerson@smith-nephew.com
Layout table for additonal information
Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01408277     History of Changes
Other Study ID Numbers: 017-101-09-030
First Submitted: August 2, 2011
First Posted: August 3, 2011
Results First Submitted: April 2, 2014
Results First Posted: May 5, 2014
Last Update Posted: July 24, 2014