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A Comparison of an Investigational Dressing to Tegaderm Matrix Wound Dressing in the Management of Diabetic Foot Ulcers

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ClinicalTrials.gov Identifier: NCT01013792
Recruitment Status : Terminated (Expired study materials; low subject recruitment)
First Posted : November 16, 2009
Results First Posted : March 23, 2015
Last Update Posted : March 23, 2015
Sponsor:
Information provided by (Responsible Party):
3M

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Foot Ulcer, Diabetic
Intervention Device: Wound Dressing
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Non-adherent Wound Dressing Tegaderm Matrix Dressing With PHI Technology
Hide Arm/Group Description Wound Dressing: Acetate mesh carrier with ointment (water, PEGs) Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
Period Title: Overall Study
Started 14 16
Completed 12 11
Not Completed 2 5
Reason Not Completed
Study suspended             2             1
Adverse Event             0             3
Lost to Follow-up             0             1
Arm/Group Title Non-adherent Wound Dressing Tegaderm Matrix Dressing With PHI Technology Total
Hide Arm/Group Description Wound Dressing: Acetate mesh carrier with ointment (water, PEGs) Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid) Total of all reporting groups
Overall Number of Baseline Participants 14 16 30
Hide Baseline Analysis Population Description
All subjects had diabetic foot ulcers between 1.0cm2 and 25.0cm2 at randomization
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 16 participants 30 participants
60.1  (7.06) 54.1  (11.01) 56.9  (9.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 30 participants
Female
2
  14.3%
4
  25.0%
6
  20.0%
Male
12
  85.7%
12
  75.0%
24
  80.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 30 participants
Asian 1 0 1
Black or African American 1 3 4
Hispanic or Latino 0 3 3
White 12 10 22
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 16 participants 30 participants
14 16 30
Diabetic foot ulcer area  
Median (Full Range)
Unit of measure:  Cm2
Number Analyzed 14 participants 16 participants 30 participants
3.1
(1.3 to 11.3)
2.8
(1.1 to 14.6)
2.8
(1.1 to 14.6)
Diabetic foot ulcer age  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 30 participants
4-12 weeks 3 3 6
13-26 weeks 4 2 6
27-52 weeks 1 1 2
>1-5 years 4 10 14
>5 years 2 0 2
1.Primary Outcome
Title Percent Diabetic Foot Ulcer Area Reduction From Baseline to Last Treatment Visit
Hide Description A positive value indicates a reduction in area relative to baseline, while a negative value indicates an increase in area relative to baseline (at time of randomization), calculated as [(Baseline - Week 8)/Baseline] x 100%.
Time Frame up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that are randomized
Arm/Group Title Non-adherent Wound Dressing Tegaderm Matrix Dressing With PHI Technology
Hide Arm/Group Description:
Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)
Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
Overall Number of Participants Analyzed 14 16
Median (Full Range)
Unit of Measure: percent change of baseline area
18.1
(-70 to 100)
34.2
(-43.9 to 100)
Time Frame 25 Weeks
Adverse Event Reporting Description Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up
 
Arm/Group Title Non-adherent Wound Dressing Tegaderm Matrix Dressing With PHI Technology
Hide Arm/Group Description Wound Dressing: Acetate mesh carrier with ointment (water, PEGs) Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
All-Cause Mortality
Non-adherent Wound Dressing Tegaderm Matrix Dressing With PHI Technology
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Non-adherent Wound Dressing Tegaderm Matrix Dressing With PHI Technology
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/14 (7.14%)      3/16 (18.75%)    
Cardiac disorders     
Subendocardial myocardial infarction  [1]  0/14 (0.00%)  0 1/16 (6.25%)  1
General disorders     
Death * [2]  1/14 (7.14%)  1 0/16 (0.00%)  0
Infections and infestations     
Ulcer/foot infection   1/14 (7.14%)  1 2/16 (12.50%)  2
Renal and urinary disorders     
Bladder Cancer   1/14 (7.14%)  1 0/16 (0.00%)  0
Vascular disorders     
Ischemic event with associate foot infection   0/14 (0.00%)  0 1/16 (6.25%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Renal failure, resulting in hemodialysis
[2]
Unexpected death in his sleep
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Non-adherent Wound Dressing Tegaderm Matrix Dressing With PHI Technology
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/14 (42.86%)      11/16 (68.75%)    
Blood and lymphatic system disorders     
Bleeding *  1/14 (7.14%)  1 0/16 (0.00%)  0
Endocrine disorders     
Hypoglycemia  [1]  0/14 (0.00%)  0 1/16 (6.25%)  2
Eye disorders     
Glaucoma   1/14 (7.14%)  1 0/16 (0.00%)  0
Gastrointestinal disorders     
Abdominal Pain *  2/14 (14.29%)  3 1/16 (6.25%)  1
Infections and infestations     
Wound/Skin Infection  [2]  4/14 (28.57%)  8 7/16 (43.75%)  9
Injury, poisoning and procedural complications     
Sprained ankle *  1/14 (7.14%)  1 0/16 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Respiratory Disorder * [3]  3/14 (21.43%)  3 3/16 (18.75%)  3
Skin and subcutaneous tissue disorders     
Pain, Trauma, Blister   5/14 (35.71%)  7 6/16 (37.50%)  8
Surgical and medical procedures     
Surgical resection   1/14 (7.14%)  1 1/16 (6.25%)  1
Vascular disorders     
Phlebitis, Edema, Swelling   2/14 (14.29%)  2 2/16 (12.50%)  3
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Dizzy spells
[2]
Infection/Cellulitis in wound or periwound skin
[3]
Upper respiratory infection
Early termination leading to small numbers of subjects analyzed
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Joseph V. Boykin, Jr., MD
Organization: HCA Retreat Hospital, Institute of Plastic and Reconstructive Surgery
Phone: 804-353-8100
EMail: joseph.boykin@HCAhealthcare.com
Publications:
Layout table for additonal information
Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT01013792     History of Changes
Other Study ID Numbers: 05-011091
First Submitted: November 13, 2009
First Posted: November 16, 2009
Results First Submitted: March 2, 2015
Results First Posted: March 23, 2015
Last Update Posted: March 23, 2015