Leg Lymphedema Clinical Trial
Official title:
Prospective, Randomized Controlled Trial Comparing the Effect of 3M Coban 2 Layer Compression System Versus Trico Bandages in the Treatment of Leg Lymphedema.
The purpose of this trial is to study the effect of the 3M Coban 2 Layer Compression System (hereafter C2L) in the treatment of leg lymphedema compared to the traditional treatment with Trico bandages.
The goal of this prospective, randomized, controlled trial with CE marked product is to
study the effectiveness (volume reduction) of 24-hour compression therapy for lymphedema,
comparing C2L and Trico bandaging. Therefore 30 patients with leg lymphedema are included.
Application of marketed compression bandages (C2L or Trico bandages) used for treatment by
trained specialists with assessment of the subbandage pressure and volume reduction.
Measurements are carried out at:
Volumetry:
Measurements after 0h, 2h and 24 h by using classic water displacement apparatus.
Pressure:
Measurements after 0h, 2h (pre and post bandage change) and 24 h;
- supine and standing to calculate the SSI;
- supine with and without dorsal flexion.
for the pressure measurement a Kikuhime (large pads) dice is used. At each new bandaging to
document the SSI and the effect of dorsiflexion in the supine position
- The subbandage pressure is measured on the medial aspect of the lower leg at the
transition of the gastrocnemius muscle into the Achilles' tendon (B1) (Partsch H. et
al. Dermatol Surg 2006; 32: 224-233).
- Fix the sensor (sensor and tube sheathed with Cellona Soft Padding)
Statistical analysis; Analysis of variance (ANOVA) comparing volume, supine subbandage
pressure with and without dorsiflexion, and SSI for the used bandages
;
Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment