Evaluating the Efficacy of the Sigvaris ULCER X Kit in Treating Venous Leg Ulcers: A Comparative Study

This MOH Focus reviews the effects of the Sigvaris ULCER X kit in the treatment of venous leg ulcers. Wearing the ULCER X kit is more effective in healing venous leg ulcers than conventional bandaging with faster healing of small ulcers <4 cm. The paper is also available in French, German, Italian, and Polish.

Evaluating the Efficacy of the Sigvaris ULCER X Kit in Treating Venous Leg Ulcers: A Comparative Study

Study aim & design

The aim of this study (1) was to assess the efficacy of a specifically designed compression stocking kit (Sigvaris ULCER X kit, “ULCER X”) in the treatment of venous leg ulcers in comparison to standard treatment with short stretch bandages.

The ULCER X consists of an understocking* worn during all times and an overstocking** worn only during the day. The short stretch bandages were worn day and night.

Participants

26 patients with ULCER X and 30 patients with short stretch bandages completed the study.

Product information

*Understocking: 15–20 mmHg

**Overstocking: 23–32 mmHg

Worn together, under- and overstocking exert a pressure of ~ 45 mmHg.

Patient randomization

Group 1: ULCER X

Group 1 wore the ULCER X kit for 4 months or until the ulcer healed.

  • Eligible: n = 30
  • Dropout: n = 4 (3 patients with donning difficulties, 1 patient refused to continue)
  • Final evaluation: n = 26

Group 2: BANDAGES

Group 2 wore bandages for 4 months or until the ulcer healed.

  • Eligible: n = 30
  • Dropout: n = 0 
  • Final evaluation: n = 30

Both groups did regular clinic visits (tracking of ulcer healing, wound dressing & patient survey).

Results

Primary outcomes = ulcer healing and subjective appraisal by patients

Complete skin closure was better within the ULCER X group (96.2%) compared to the BANDAGES group (70%).

Healing time of ulcers <4 cm was twice as fast with ulcer x compared to bandages. in ulcers>4cm there was no difference in healing time between ULCER X and bandages.

ULCER X increased the quality of life for patients. It reduced pain and discomfort and it increased participation in activities.

Conclusion

Wearing the ULCER X kit is more effective in healing venous leg ulcers than conventional bandaging with faster healing of small ulcers <4 cm. this study demonstrates that the sigvaris ulcer x kit can be effectively used for the treatment of venous leg ulcers.>

In addition, the results show that participation in normal activities increases, while pain and discomfort are reduced in patients treated with the ULCER X kit.

Author's suggestion

Treatment of common venous leg ulcers with the SIGVARIS ULCER X kit is more effective than conventional bandaging and better perceived by patients.

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