Vasculogenic Chronic Ulcer: Tissue Regeneration with an Innovative Dermal Substitute

Abstract

The healing of venous and arterial ulcers is slow, and in some cases, they may not heal at all. This study aims to demonstrate the clinical advantage of Nevelia^®, an innovative collagen dermal template substitute (DS) in venous and arterial chronic ulcers treatment. 35 patients affected by chronic vascular ulcers with a mean area of 35.1 ± 31.8 cm² were treated with DS followed by autologous dermal epidermal graft (DEG). Follow-up was performed at 7-14-21 and 28 days after DS implant and 7-14-21 and 28 days after DEG. At 28 days after DEG, the mean values of Manchester Scar Scale was of 1.8 ± 0.7 for skin color, 1.6 ± 0.7 for skin contour, 1.7 ± 0.7 for distortion, and 1.7 ± 0.7 for skin texture, whereas skin was matte in 27 patients (77%) and shiny in the remaining eight cases (23%). Histological findings correlate with the clinical result showing a regenerated skin with reactive epidermal hyperplasia and dermal granulation tissue after two weeks (T1), and after three weeks (T2) a re-epithelialization and a formed new tissue architecture analogue to normal skin physiology. These data suggest that Nevelia^® could be useful to treat chronic venous and arterial ulcers.

Keywords: Nevelia; arterial; chronic ulcers; collagen; dermal substitute; venous.

Chart 1

The frequency of each category of Texas scale in the sample of enrolled patients.

Figure 1

Surgical Protocol. (A) Vascular ulcer, pre-operative situation; (B) careful debridement; (C) implant of dermal substitute; (D) remodelling.

Chart 2

Manchester scar scale (MSS) at 28 days after dermal epidermal graft (DEG). Box whiskers plot reporting median (bold line), first and third quartiles (borders of the boxes) and minimum and fourth quartiles (borders of whiskers). For matte shiny, all the data converged into the line with the exception of one patient, represented by the star and considered as an outlier because out of 1.5 of the inter-quartile range.

Chart 3

Visual analogue scale (VAS). Box whiskers plot reporting median (bold line), minima (lower line), first and third quartiles (borders of the boxes) and fourth quartiles (borders of whisker) of VAS-score about pain before and after intervention and the aesthetic judgment given using Rosenberg-scale.

Chart 4

Kaplan-Meier plot. The percentage of completely healed-wound during the observation period.

Figure 2

Clinical case. (A) Preoperative situation of patient affected by vascular ulcer of left lower limb; (B) Postoperative situation showing healing 28 days after DEG; (C) Follow-up period during DS application.

Figure 3

Clinical case. (A) Preoperative situation of patient affected by vascular ulcer of the back portion of the calf; (B) Follow-up period during DEG application; (C) postoperative situation showing healing 28 days after DEG; (D) post-operative situation one year after DEG.

Figure 4

Microscopic aspects of wound healing and neo-angiogenesis after Nevelia^® application. Representative microscopic images of Hematoxylin & Eosin-stained paraffin sections of skin biopsies at baseline (T0) showing a typical ulcer with cellular debris. After the dermal substitute application at T1 (after two weeks) and at T2 (after three weeks), skin punch biopsies showed wound healing with re-epithelialization, dermal granulation tissue with collagen deposition and newly formed vessels (arrowheads). The presence of Nevelia^® is still evident in dermal tissue at T1 and T2 (arrows). Scale bar = 5 µm.