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A Study to Look at the Effects of Four Weeks of Treatment on the Healing of Diabetic Foot Ulcers

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ClinicalTrials.gov Identifier: NCT01143714
Recruitment Status : Completed
First Posted : June 14, 2010
Results First Posted : May 3, 2013
Last Update Posted : May 6, 2013
Sponsor:
Information provided by (Responsible Party):
Healthpoint

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Diabetic Foot Ulcers
Interventions Drug: Santyl
Other: White Petrolatum
Enrollment 57
Recruitment Details Adults aged 18 years and older, with a diabetic foot ulcer that has not responded to treatment
Pre-assignment Details  
Arm/Group Title Collagenase Santyl Ointment Vehicle (White Petrolatum)
Hide Arm/Group Description Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks. White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
Period Title: Overall Study
Started 29 28
Completed 22 25
Not Completed 7 3
Reason Not Completed
Adverse Event             4             2
Withdrawal by Subject             1             0
Subject non-compliance             0             1
wound closed = deemed healed             1             0
wound size increased             1             0
Arm/Group Title Collagenase Santyl Ointment Vehicle (White Petrolatum) Total
Hide Arm/Group Description Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks. White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks. Total of all reporting groups
Overall Number of Baseline Participants 29 28 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 28 participants 57 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
  69.0%
19
  67.9%
39
  68.4%
>=65 years
9
  31.0%
9
  32.1%
18
  31.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 28 participants 57 participants
60.0  (9.4) 59.9  (12.4) 59.9  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 28 participants 57 participants
Female
8
  27.6%
5
  17.9%
13
  22.8%
Male
21
  72.4%
23
  82.1%
44
  77.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants 28 participants 57 participants
29 28 57
1.Primary Outcome
Title Change in Wound Area
Hide Description The primary efficacy endpoint was the percent change in wound area from baseline to completion of the 4-week treatment phase and the 8-week follow-up period
Time Frame 4 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Sample size originally set at 100 to provide 80% power, a=0.05. Interim analysis when enrollment reached 50 indicated results would not change with additional enrollment. Intent-to-treat used for primary inference; Missing values imputed by method of population mean and last observation carried forward (wound area).
Arm/Group Title Collagenase Santyl Ointment Vehicle (White Petrolatum)
Hide Arm/Group Description:
Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
Overall Number of Participants Analyzed 29 28
Least Squares Mean (Standard Error)
Unit of Measure: percentage of average change in wound
Treatment Phase -32.74  (7.12) -33.08  (7.13)
Follow-up Period -49.34  (12.34) -34.27  (12.36)
2.Secondary Outcome
Title Number of Sharp Debridements Performed During the 4-week Treatment Phase and the 8-week Follow-up Period (12 Weeks Total)
Hide Description [Not Specified]
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population
Arm/Group Title Collagenase Santyl Ointment Vehicle (White Petrolatum)
Hide Arm/Group Description:
Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
Overall Number of Participants Analyzed 29 28
Least Squares Mean (Standard Error)
Unit of Measure: debridements
1.38  (0.22) 1.5  (0.22)
Time Frame 12 weeks
Adverse Event Reporting Description Covered both 4 week treatment phase and the 8 week follow-up period.
 
Arm/Group Title Collagenase Santyl Ointment Vehicle (White Petrolatum)
Hide Arm/Group Description Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks. White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
All-Cause Mortality
Collagenase Santyl Ointment Vehicle (White Petrolatum)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Collagenase Santyl Ointment Vehicle (White Petrolatum)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/29 (13.79%)      4/28 (14.29%)    
Cardiac disorders     
Cardiac Failure  1  1/29 (3.45%)  1 0/28 (0.00%)  0
Infections and infestations     
Necrotizing Fasciitis  1  0/29 (0.00%)  0 1/28 (3.57%)  1
Osteomyelitis  1  1/29 (3.45%)  1 1/28 (3.57%)  1
Sepsis  1  0/29 (0.00%)  0 1/28 (3.57%)  1
Staphylococcal bacteraemia  1  1/29 (3.45%)  1 0/28 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1  1/29 (3.45%)  1 0/28 (0.00%)  0
Hand Fracture  1  0/29 (0.00%)  0 1/28 (3.57%)  1
Metabolism and nutrition disorders     
Diabetic ketoacidosis  1  1/29 (3.45%)  1 0/28 (0.00%)  0
Hyperglycaemia  1  1/29 (3.45%)  1 0/28 (0.00%)  0
Hypoglycaemia  1  1/29 (3.45%)  1 0/28 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Pain in Extremity  1  0/29 (0.00%)  0 1/28 (3.57%)  1
Renal and urinary disorders     
Renal Failure Acute  1  1/29 (3.45%)  1 0/28 (0.00%)  0
Renal Injury  1  0/29 (0.00%)  0 1/28 (3.57%)  1
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%
Collagenase Santyl Ointment Vehicle (White Petrolatum)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/29 (3.45%)      5/28 (17.86%)    
Infections and infestations     
Cellulitis  1  0/29 (0.00%)  0 2/28 (7.14%)  2
Skin and subcutaneous tissue disorders     
Diabetic Ulcer  1  1/29 (3.45%)  1 3/28 (10.71%)  3
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 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.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release.
Results Point of Contact
Name/Title: Jaime E. Dickerson, PhD; Sr. Director Clinical Affairs
Organization: Healthpoint, Ltd.
Phone: 817-302-3914
Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01143714     History of Changes
Other Study ID Numbers: 017-101-09-024
First Submitted: June 11, 2010
First Posted: June 14, 2010
Results First Submitted: March 13, 2013
Results First Posted: May 3, 2013
Last Update Posted: May 6, 2013