Double blind randomised controlled trial

Evaluation of the efficacy and tolerance of UrgoStart® and neutral foam dressing (Urgocell® TLC) in the treatment of venous leg ulcers: double blind randomised controlled trial.

National coordinator: Doctor Sylvie MEAUME, Head of Geriatrics Department, Charles Foix Hospital, APHP, Ivry sur Seine, France.

Methods

Phase III, multicentre, controlled, randomised study conducted in two parallel groups and double blind (187 patients).
Trial conducted in France in 45 hospital investigator centres (Dermatology and Vascular Medicine departments). 8 week RCT.

Description of the population at inclusion

At inclusion, population and wounds studied had the following characteristics:

At inclusion, the two groups were comparable, for both patients and wounds characteristics; no significant difference (above the 5% threshold) in any of the parameters was detected between the two groups.

Results

Evolution of the wound surface area after 8 weeks follow-up

After 8 weeks follow up, a highly significant difference between the two groups was noted; the median wound surface area reduction was 58.3% in the UrgoStart® group and 31.6% in the neutral foam dressing group (p=0.0021).

a) Evolution of the wound surface area after 8 weeks follow-up (absolute value in cm2)
Healing speed in mm2/day of treatment was 10.83mm2/day of treatment (UrgoStart®) and 5.15mm2/day for neutral foam dressing (p=0.0056) confirming faster healing rates and faster recovery time.

b) Percentage of ulcers with a wound surface area reduction of at least 40% after 8 weeks
The minimum 40% wound surface area reduction versus the initial surface is a substitution criteria described in the scientific literature as highly predictive of a wound closure at 20-24 weeks treatment.
After 8 weeks follow-up, the percentage of patients reaching 40% of wound surface area reduction was 65.6% and 39.4% in the (UrgoStart®)and neutral foam dressing groups respectively (p= 0.0003).

c) Quality of life
Each patient from the study documented a questionnaire on quality of life (EuroQuol 5D) including 5 parameters (Mobility, Autonomy, Activity, Pain and Anxiety-Depression) and a VAS (Visual Analogical Scale) at the start and end of treatment. After 8 weeks follow-up, a significant difference was seen in favour of the (UrgoStart®) group in two of the five evaluated parameters : Pain (p=0.022) and Anxiety-Depression (p=0.037), the VAS scale was slightly too high (p=0.072) to be significant.
The three remaining parameters were not affected by the type of dressing used.

d) Tolerance and acceptability of the treatments
No significant difference between the two treatment groups were observed in terms of local adverse events or acceptability: Ease of application, ease of removal, pain at removal, pain between two dressing changes, bleeding on removal, maceration and odour.

Randomised controlled trial

Evaluation of the efficacy and tolerance of the TLC-NOSF dressing versus a comparative product in the treatment of venous or mixed predominantly venous leg ulcers.

 

National Coordinator : Professor Jean-Luc SCHMUTZ Head of the Dermatology Department. Fournier Hospital, Nancy Regional University Hospital Center

Methods:

Phase III, multicentre, controlled, randomised, open study
Trial conducted in 27 investigator centres in France and the United Kingdom. Trial conducted in two parallel groups in both hospitalised and out-patients for a maximum duration of twelve weeks.

117 patients presenting with venous leg ulcers, all treated with compression bandaging.

Description of the population at inclusion:

  • Large surface area : > 10 cm² in 41 % of cases
  • Stagnation or worsening in 68% of cases
  • Long duration of wound (median 10 months, 56% > 6 months)
  • Recurrent in 61% of wounds
  • History of phlebitis : 25% of cases
  • Overweight patients

Results

This RCT demonstrated:

  • A significant greater reduction in wound surface area after 12 weeks: 54.4% reduction with TLC-NOSF versus 13% with the comparative MMP inhibitor product
  • A significant higher number of patients responding to TLC-NOSF treatment: 56.1% of patients achieved a surface area reduction of 40% versus 35% with the comparative MMP inhibitor product (40% is defined as being predictive of total healing)
  • A faster healing rate of 5.5mm 2 /day of treatment with TLC-NOSF versus 1.5mm 2 /day with the comparative MMP inhibitor product.

 

Clinical cases

Case n°1 Case n°2 Case n°3 Case n°4
Cas N°1

Click on picture to see the results with START

 Cas N°2

Click on picture to see the results with START

 Cas N°3

Click on picture to see the results with START

 Cas N°4

Click on picture to see the results with START

Patient with an extensive venous leg ulcer (140 cm2), present for 2 years and demonstrating no tendency to heal despite concurrent venous compression. Numerous dressings of all categories had been used to date with no success and the wound had undergone a succession of exuding and fibrinous stages obstructing resumption of the healing process.
The introduction of TLC-NOSF led to a rapid therapeutic response, clearly visible from D30. At D90, the ulcer was totally healed.

 

40 year-old patient, (allergic to LMWH and with a protein C deficiency), presenting a non-recurrent external supra-malleolar venous leg ulcer on the left leg, present for 3 months.
On inclusion, the dressing removed is a conventional hydrocellular one, the skin around the wound is eczematous and macerated and the patient complains of constant, severe pain.
After six weeks of treatment, wound healing is almost complete, with a reduction in Wound surface area of 94.34%.

 

57 year-old male patient with a history of hypertension, high cholesterol, insulin-dependent diabetes, peripheral arterial disease, amputation of the right 4th toe due to infected necrosis in August 2007. The patient presented with a wound on the top of the foot with the amputation site, baring the tendons.
At inclusion, when commencing the TLC-NOSF dressing, the wound measured 22 cm2 (6.3 x 3.5 cm) and a depth of 1 cm. After one month, the tendons were almost covered and after 4.5 months (+135 D), the wound surface area had decreased to 3 cm2 ( 86.4% reduction).

41 year-old male patient, presenting with a sacral pressure ulcer, closed in 2007 by a surgical skin flap (greatest gluteal). January 2008, two pressure ulcers: left buttock and left ischium, not healing for one year despite an attempt at direct closure then directed healing.
At inclusion, when commencing the TLC-NOSF dressing, the left buttock pressure ulcer measured 5 cm2 (2.5 x 2 cm) (1), and the left ischial pressure ulcer measured 7 cm2 (3.5 x2 cm) (2).
At D+36, the wound surface area (1) had decreased by 64% to 1.8 cm2 and that of wound (2) by (14%) to 6 cm2.
After 3 months of treatment, wound healing was almost complete.

 

Observational study

Design

An observational study has been completed and demonstrates the efficacy of URGOSTART®.

2052 patients presenting with venous leg ulcers, pressure ulcers, diabetic foot ulcers.
483 centres in Germany.
6 weeks follow up.

Description of the population at inclusion:

  • A high population of diabetic patients: 43.5%
  • A high population of obese patients: 22.4%
  • Large surface area = 10cm2

Results

The main results of this observational study were:

  • A 75% reduction in wound surface area after 6 weeks with URGOSTART®

This observational study also demonstrated :

  • 93.5% of the patients were satisfied with the dressing
  • 96% of the patients found the dressing comfortable

Clinical study

Evaluation of the efficacy and tolerance of UrgoStart® Contact in the local management of diabetic foot ulcers: a pilot multicentre clinical study

Main author: J. L. RICHARD, Head of Department, Nutritional Diseases and Diabetology Department, University Hospital, Nimes, France.

Methods

This open-label, un-controlled, un-blinded pilot study was conducted with 34 patients (mean diabetes duration: 17 years) suffering from grade 1A (University of Texas classification) DFUs.
Patients were followed up twice a month during a 12 week period with clinical, planimetric and photographic assessment.

Description of the population at inclusion

At baseline, mean duration of the wound was 6.7±5.2 months (mean±SD) and wound area was 2.7±2.4 cm2.

Results

After treatment with UrgoStart® Contact , wound area decreased by an average of 63%. Complete healing was observed in 10 patients after a mean treatment time of 8.8±3 weeks; 17 wounds were judged as improved according to the investigators. Three adverse events occurred (1 deterioration and 2 maceration) but none required stopping the treatment. Acceptability of the dressing was considered good by both health care professionals and patients.

Clinical study

Effect of UrgoStart® in the local management of pressure ulcers

Main author: V. RETHORE, Elderly Care Department, Lagny sur Marne Hospital, France

Methods

This study was an open multicentre, non-comparative clinical trial. At baseline, pressure ulcer area ranged from 3 to 50cm2, with granulation tissue covering =50 % of the wound bed. For each patient included, clinical, planimetric (area tracings) and photographic evaluations were recorded weekly, during the 6 week follow-up, using standardised protocols. The relative rate of healing, determined through the surface area reduction was selected as the primary efficacy criterion of this study.

Description of the population at inclusion

The 25 patients included in the trial were followed during the 6 week period. Mainly located on sacral and heel areas, the baseline mean wound area was 6.56cm2.

Results

The wound surface area reduced by an average of 43.8% to 4.19cm2 at the end of treatment. Complete healing was obtained in 3 patients in an average time of 27 days. Two local adverse events occurred under the tested dressing (overgranulation) in the same patient.