Macrophage stimulating agent for diabetic foot ulcers

NewsBot · Dec 7, 2013

Members do not see these Ads. Sign Up.
Macrophage stimulating agent soluble yeast β-1,3/1,6-glucan as a topical treatment of diabetic foot and leg ulcers: A randomized, double blind, placebo-controlled phase II study
Svetlana N Zykova et al
Journal of Diabetes Investigation; Early View

Aims/Introduction
Dysregulated inflammatory response is believed to be an important factor in the pathogenesis of several late complications of diabetes mellitus. β-Glucans are potent inducers of immune function. The present randomized, double blind, two-center, placebo-controlled study was undertaken to explore safety, tolerability and efficacy of soluble β-1,3/1,6-glucan (SBG) as a local treatment of diabetic foot ulcers.
Materials and Methods
A total of 60 patients with type 1 or 2 diabetes and lower extremity ulcers (Wagner grade 1–2, Ankle/Brachial Index ≥0.7) received SBG or a comparator product (methylcellulose) locally three times weekly up to 12 weeks in addition to conventional management scheme. A total of 54 patients completed the study.
Results
A tendency for shorter median time to complete healing in the SBG group was observed (36 vs 63 days, P = 0.130). Weekly percentage reduction in ulcer size was significantly higher in the SBG group than in the methylcellulose group between weeks 1–2, 3–4 and 5–6 (P < 0.05). The proportion of ulcers healed by week 12 was also in favor of SBG (59% vs 37%, P = 0.09), with a significantly higher healing incidence in the SBG group at week 8 (44% vs 17%, P = 0.03). SBG was safe and well tolerated. There was a clinically significant difference regarding the incidence of serious adverse events in favor of the SBG treatment.
Conclusions
Local treatment of diabetic lower extremity ulcers with β-1,3/1,6-polyglucose shows good safety results. This β-glucan preparation shows promising potential as a treatment accelerating cutaneous healing. Further studies are required to confirm this effect.
Click to expand...

NewsBot · Jul 6, 2026

Non-Randomised Comparative Analysis and Cost-Minimisation Analysis of Macrophage-Modulating Cream on Mildly Infected Diabetic Foot Ulcers: A Real-World Preliminary Report
Chia-Ding Shih et al
Int Wound J. 2026 May;23(5):e70937. doi: 10.1111/iwj.70937.

Diabetic foot ulcers (DFUs) are serious complications of diabetes, characterised by impaired healing driven in part by pro-inflammatory macrophage activity. ON101, a topical macrophage-modulating cream, promotes M1-to-M2 transition and improves wound healing. We prospectively enrolled patients with Wagner Grade 2 DFUs and mild infection per the Infectious Diseases Society of America criteria to receive ON101 with weekly follow-up. Exclusions included dialysis dependence and inadequate arterial perfusion. The primary endpoint was a 4-week healing outcome. The secondary analysis compared direct costs to a 1:1 retrospective standard of care cohort matched on wound locations and natural history. A total of 12 cases were analysed (mean age: 65.8 years in the ON101 group; 64.6 years old in the control group, p = 0.957). No adverse events occurred. The mean paired difference at the 4-week healing outcome of ON101 was an 87% reduction (95% bootstrap CI: 9.0-244.0) versus the control group. Direct cost per wound healed was approximately 19% lower with ON101. Subjects receiving ON101 demonstrated a significantly faster wound-healing rate within 4 weeks. The direct cost difference between ON101 and SOC mirrored lower resource use. A larger, randomised study with longer follow-up is required to determine the robustness, generalisability and durability of these preliminary results.
Click to expand...

NewsBot · Sep 12, 2026

Successful Healing of a Chronic Distal Toe Ulcer with Tendon Exposure Using the Topical Macrophage Regulator ON101
Chao-Hsin Huang et al
Plast Reconstr Surg Glob Open. 2026 Sep 10;14(9):e8115.

Diabetic foot ulcer (DFU) is one of the most challenging complications of diabetes mellitus. Chronic hyperglycemia contributes to impaired immune function, characterized by failure of macrophage polarization from the proinflammatory M1 to the prohealing M2 phenotype, together with increased release of inflammatory mediators. ON101 is a novel macrophage-regulating topical agent derived from botanical extracts, designed to suppress proinflammatory cytokines, restore M1/M2 macrophage balance, and promote collagen synthesis. We report the case of a 77-year-old man with diabetes mellitus who presented with a chronic, nonhealing ulcer of the right fifth toe with exposed tendon, persisting for 2 years despite conventional wound care and twice-daily Aquacel Ag+ extra dressing changes. The wound was accompanied by local inflammation, whereas angiographic evaluation suggested preserved distal runoff without evidence of critical macrovascular occlusion. ON101 topical therapy was initiated once daily under PolyMen dressing, leading to progressive granulation tissue formation, epithelial coverage of the tendon, and complete wound closure within 2 months. Notably, the total amount of ON101 used throughout the treatment course was less than 1 15-g tube. Given the chronicity of the wound, the presence of exposed tendon, and the difficulty of achieving durable healing in distal diabetic toe ulcers, this case suggests that ON101 may provide substantial therapeutic benefit in selected refractory cases.
Click to expand...

Macrophage stimulating agent for diabetic foot ulcers

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

Macrophage phenotype switching in diabetic wounds

Granulocyte-colony stimulating factors as adjunctive therapy for diabetic foot infections

Share This Page

Macrophage stimulating agent for diabetic foot ulcers

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

Macrophage phenotype switching in diabetic wounds

Granulocyte-colony stimulating factors as adjunctive therapy for diabetic foot infections

Share This Page

Useful Searches