Randomized controlled trial on collagen/oxidized regenerated cellulose/silver treatment

Area of Science:

• Biomedical Engineering
• Wound Healing Research
• Materials Science in Medicine

Background:

• Chronic wounds, such as diabetic foot ulcers, present significant challenges due to impaired healing and biochemical imbalances.
• The wound microenvironment plays a critical role in healing, with protease activity often dysregulated in non-healing wounds.
• Collagen/oxidized regenerated cellulose (ORC)/silver therapy is a novel approach designed to modulate the wound environment.

Purpose of the Study:

• To evaluate the efficacy of collagen/oxidized regenerated cellulose (ORC)/silver therapy in treating diabetic foot ulcers.
• To compare the outcomes of collagen/ORC/silver therapy against standard treatment (control).
• To investigate the role of protease levels in predicting wound healing response.

Main Methods:

• A randomized controlled study involving patients with diabetic foot ulcers.
• Patients were assigned to either collagen/ORC/silver therapy or standard treatment.
• Wound area measurements and wound fluid analysis for protease levels (MMP-9, elastase) were conducted weekly.

Main Results:

• A significantly higher proportion of patients in the collagen/ORC/silver group achieved ≥50% wound area reduction by week 4 (79% vs. 43%, p = 0.035).
• The collagen/ORC/silver group experienced significantly fewer study withdrawals due to infection (0% vs. 31%, p = 0.012).
• Elevated levels of matrix metalloproteinase-9 and elastase were associated with non-response to treatment.

Conclusions:

• Collagen/ORC/silver therapy effectively promotes diabetic foot ulcer healing by normalizing the wound microenvironment and mitigating infection.
• Combined protease level measurement may serve as a more accurate prognostic marker for wound healing than individual proteases.
• This therapy offers a promising solution for managing complex chronic wounds.