Skin is the largest organ in the human body and consists of three layers of epidermis, dermis, and hypodermis (subcutaneous tissue) (
1). Wound healing includes several stages, such as homeostasis, inflammation, proliferation, and remodeling (
2). Diabetes is one of the most costly and common diseases worldwide as of now. Approximately, 15% of diabetic patients develop diabetic foot ulcers (
3). Chronic diabetic ulcers are difficult to treat and impose a cost burden on the patient and the health care system in the community. Generally, in comparison with the acute ulcer, a chronic ulcer contains a large concentration of IL-1, IL-6, and TNF-α. According to the data, the level of pro-inflammatory cytokines (TNF-α, IL-1β) in chronic ulcers were about 100 times more than acute ulcers; on the other hand, the mitogenic activity, division rate, and cell differentiation were significantly lower in the reports (
4). One of the effective treatments for chronic ulcers is the disruption of the pro-inflammatory cycle (
5). The matrix metalloproteinase (MMP) is a zinc-dependent protease and can degrade the entire extracellular matrix compounds (
6). Normally, the tissue fibroblast inhibitors called (tissue inhibitor of metalloproteinase) TIMP-1, 2, 3, and 4 exist in the human body tissues (
7). The two indispensable MMPs are Gelatinase A (MMP-2) and Gelatinase B (MMP-9), which could degrade the entire active forms of the extracellular matrix (ECM) collagen (
8). Pro-inflammatory cytokines can play a major role in the regulation and expression of MMPs, especially MMP-2,9. One of the cytokines known to have an anti-inflammatory role is interleukin-10 (IL-10) (
9). Distinctly, IL-10 has been shown to stimulate TIMP-1 secretion and inhibit the secretion of MMP-2 and MMP-9 by prostate tumor cells (
10). It also exerts inhibitory effects on pro-inflammatory cytokines (
9). Chitosan is a natural biocompatible, biodegradable, non-antigenic polymer with anti-microbial effects and is obtained from chitin (
11,
12). Studies have shown that chitosan has coagulation, antioxidant, and wound-healing properties (
13-
17). Polyvinyl alcohol is a synthetic polymer used in the pharmaceutical and cosmetic industries (
18). Doxycycline is a synthetic broad-spectrum antibiotic in the tetracycline family (
19,
20). In addition to acting as antibiotics, tetracyclines can also affect inflammation, regulation of the immune system, cell proliferation, and angiogenesis (
21-
24). Various studies have indicated that doxycycline has been capable in inhibit pro-inflammatory cytokines, and MMPs (
25). Results of a study in 2009 showed that doxycycline inhibited IL-1β mRNA and decreased its bioactivity (
26). Doxycycline also led to a significant inhibition in the production of TNF-α, IL-6, IL-8, and down-regulation of the NF-κB gene (
27). In one study, it was revealed that this drug significantly inhibited IL-1β and TNF-α cytokines (
28). Electrospinning is a method, in which electrostatic forces are used to produce nanofibers from polymeric solutions (
29). These types of wound dressing improve and enhance cell-cell and matrix-cell responses along with the gene expression and normal phenotypic shape of cells (
30). Evaluation and determination of the effect of doxycycline and chitosan in chronic wound healing is the novelty of the present study. In our pervious study, we evaluated the physiochemical (scanning electron microscope (SEM), Fourier-transform infrared spectroscopy (FTIR spectroscopy), dissolution test, permeation test, swelling test, agar diffusion antibiogram) of different formulation of films and nanofibers based on chitosan/polyvinyl alcohol/Doxycycline 1% with and whitout Genipin (crosslinker). We found that the chitosan/polyvinyl alcohol/Doxycycline 1% film and nanofiber had better release
in-vitro studies for films and nanofiber wound dressing. So, this formulation was selected for this study (
31). The present study was aimed to compare the effect of two film and nanofiber formulations containing chitosan, polyvinyl alcohol, and doxycycline on the wound healing rate, concentration of Interleukin-1β (IL-1β), tumor necrosis factor (TNF-α), Interleukin-10 (IL-10), matrix metalloproteinase (MMP-2), tissue inhibitor of metalloproteinase (TIMP-1), and histology and tissue stereology in the wound site in a model of diabetic rat.