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

 

Design

A Randomized Controlled Trial has been completed and demonstrates the efficacy of TLC-NOSF versus a comparative MMP inhibitor product in the treatment of venous or mixed prodomnantly 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.

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

The main results of this RCT were :

  • A greater reduction in wound surface area with TLC-NOSF
  • A greater number of patients responding to treatment with TLC-NOSF
  • A faster healing rate with TLC-NOSF

This RCT demonstrated:

  • A significant greater reduction in wound surface area after 12 weeks: 54.4% reduction with TLC-NOSF versus 13% with Promogran ®
  • 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 Promogran.

 

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 ofURGOCELL® START TLC.

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 URGOCELL® START TLC

This observational study also demonstrated :

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