Venous Leg Ulcer
Conditions
Keywords
non-inferiority, randomized, TulleGras, Urgotul, pain, venous leg ulcer, healing
Brief summary
Evaluation of the non-inferiority of TulleGras M.S.® versus Urgotul® in pain associated with removal of wound dressing during care of venous leg ulcer
Interventions
DEVICEUrgotul
sterile, hydrocolloid dressing, that consist of a polyester fabric coated with hydrocolloid particles and vaseline
DEVICETulleGras M.S.
Sterile dressing that consists of viscose tissue coated with mineral vaseline
Sponsors
CEN Biotech
Mylan Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject informed of the objectives, purpose, details and constraints of the study and who has given his/her written informed consent. * Male or female subject. * Subject at least 45 years of age. * Subject presenting with an open venous leg ulcer. * Age of venous leg ulcer between 1 month and 12 months inclusive at the Inclusion Visit (Visit 1). * Venous leg ulcer whose area is between 4 cm2 and 50 cm2 inclusive at the Inclusion Visit (Visit 1). * Venous leg ulcer in the granulation phase over 50% of its area at the Inclusion Visit (Visit 1);
Exclusion criteria
Related to the disease studied: * Venous leg ulcer for which surgery is indicated or for which a surgical procedure is planned within twelve weeks of inclusion in the study (Visit 1). * Venous leg ulcer at start of cleaning phase; * Fibrinous and dry ulcer (non exudative wound) or on the contrary highly exudative and/or hemorrhagic. * Venous leg ulcer with signs of critical colonization or clinically infected. * Cancerous venous leg ulcer. Related to the subject: * Subject presenting with a serious systemic disease, which may lead to premature termination of the study before the end of the twelve weeks of treatment of the Follow up Period. * Subject with a medical history or a significant disease revealed by history which can limit his/her participation or prevent the subject from completing the study. * Subject presenting with a progressive neoplasm, treated with radiotherapy or chemotherapy or immunosuppressant therapy or high-dose corticosteroids. * Subject who underwent surgery directly related to his/her venous disease during the two months prior to Inclusion Visit (Visit 1). * Subject with poorly controlled diabetes. * Subject who presented with a deep venous thrombosis during the 3 months prior to Inclusion Visit (Visit 1). * Subject confined to bed. * Woman of child-bearing potential (NOT postmenopausal for at least 24 months or NOT surgically sterilized (tubal ligation) or NOT hysterectomized) who is NOT routinely using adequate and efficient hormonal contraception or barrier method (intrauterine device, diaphragm, combination of condom and spermicide) prior to and during the trial. * Subject whose ankle has a circumference, measured at the Inclusion Visit (Visit 1), greater than 32 cm (\> 32 cm). * Subject presenting with symptomatic or asymptomatic peripheral arterial disease, particularly with a distal systolic pressure index, measured at the Inclusion Visit (Visit 1), ≤0.8 or ≥1.3. * Subject with a history of allergic reaction(s) to one of the different components of the dressings or with a contra-indication to the use of one of these dressings. * Known history of alcohol abuse or drug abuse. * Subject linguistically or psychologically unable to understand the information given and to provide informed consent. * Subject participating in or who participated in another clinical study within 4 weeks prior to the Inclusion Visit (Visit 1). * Subject not covered by or not a beneficiary of the Social Security system. * Subject deprived of his freedom as the result of a legal or administrative decision or subject to legal guardianship. * Any other reason, in the investigator's opinion, that prohibits the inclusion of the subject into the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity at Removal of the Primary Dressing, Evaluated by the Subject Just After Removal | at the time of dressing removal on Day 2 (Visit 2) and Day 4 (Visit 3) | Pain intensity experienced by subjects associated to removal of each study primary dressings during the care, assessed at of the Cross-over Period on a visual analogue scale (VAS). The VAS was provided as a 100 mm, non-graduated horizontal line, with extremities indicating no pain (0) and extreme pain (100). The subject responded by drawing a vertical line to assess the pain intensity he/she experienced at the time of removal of the primary wound dressing. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TulleGras MS - Urgotul Cross-over period: one dressing of TulleGras M.S. for two days, then one dressing of Urgotul for two days; Follow-up period: Urgotul for a maximum duration of 12 weeks | 31 |
| Urgotul - TulleGras M.S. Cross-over period: one dressing of Urgotul for two days, then one dressing of TulleGras M.S. for two days; Follow-up period: TulleGras M.S. for a maximum duration of 12 weeks | 31 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Total | TulleGras MS - Urgotul | Urgotul - TulleGras M.S. |
|---|---|---|---|
| Age, Continuous | 77.9 years STANDARD_DEVIATION 12.1 | 78.3 years STANDARD_DEVIATION 10.5 | 77.5 years STANDARD_DEVIATION 13.7 |
| Region of Enrollment France | 62 Participants | 31 Participants | 31 Participants |
| Sex: Female, Male Female | 44 Participants | 24 Participants | 20 Participants |
| Sex: Female, Male Male | 18 Participants | 7 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 2 / 31 |
| other Total, other adverse events | 4 / 31 | 3 / 31 |
| serious Total, serious adverse events | 3 / 31 | 7 / 31 |
Outcome results
Primary
Pain Intensity at Removal of the Primary Dressing, Evaluated by the Subject Just After Removal
Pain intensity experienced by subjects associated to removal of each study primary dressings during the care, assessed at of the Cross-over Period on a visual analogue scale (VAS). The VAS was provided as a 100 mm, non-graduated horizontal line, with extremities indicating no pain (0) and extreme pain (100). The subject responded by drawing a vertical line to assess the pain intensity he/she experienced at the time of removal of the primary wound dressing.
Time frame: at the time of dressing removal on Day 2 (Visit 2) and Day 4 (Visit 3)
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TulleGras M.S. | Pain Intensity at Removal of the Primary Dressing, Evaluated by the Subject Just After Removal | 11.9 units on a scale: 0-100 mm | Standard Deviation 15.6 |
| Urgotul | Pain Intensity at Removal of the Primary Dressing, Evaluated by the Subject Just After Removal | 11.7 units on a scale: 0-100 mm | Standard Deviation 16.7 |
95% CI: [-1.339, 1.864]