What is the evidence supporting the use of sucrose-octosulfate hydrogel formulations, such as Suprathel (sucrose-octasulfate), for diabetic foot wounds?

Sucrose-Octosulfate Hydrogel Formulations for Diabetic Foot Wounds

Brand Name and Availability

The commercially available sucrose-octosulfate impregnated dressing is marketed under the brand name UrgoStart (manufactured by Laboratoires Urgo Medical), which can be readily purchased through medical supply distributors. 1

Evidence Supporting Use

When to Use Sucrose-Octosulfate Dressings

Consider sucrose-octosulfate impregnated dressings specifically for non-infected, neuro-ischemic diabetic foot ulcers that have failed to show adequate healing after at least 2 weeks of best standard care (including appropriate off-loading). 2

The 2024 IWGDF guidelines provide a conditional recommendation with moderate certainty of evidence for this specific clinical scenario. 2

Supporting Evidence Quality

The recommendation is based on one large, double-blind, multinational randomized controlled trial (the EXPLORER study) that was assessed to be at low risk of bias. 2, 1 This study demonstrated:

• Significantly improved complete wound healing at week 20: 48% in the sucrose-octasulfate group versus 30% in the control group (18 percentage point difference, adjusted odds ratio 2.60,95% CI 1.43-4.73; p=0.002) 1
• Faster estimated time to heal compared to placebo dressing 2
• Increased percentage area reduction compared to control 2
• Favorable safety profile with few reported harms 2

A 2024 meta-analysis further confirmed that advanced wound dressings, particularly sucrose-octasulfate, significantly promote wound healing and shorten time-to-healing in diabetic foot ulcers (weighted mean difference: -24.38 days, p=0.010). 3

Mechanism of Action

Sucrose-octasulfate works by inhibiting matrix metalloproteinases, which are enzymes that can impair wound healing in chronic wounds. 4 Multiple sequential clinical studies have demonstrated significant promotion of wound healing with TLC-sucrose octasulfate (Technology Lipido-Colloid) products. 4

Clinical Algorithm for Implementation

Step 1: Patient Selection Criteria

• Ulcer type: Non-infected, neuro-ischemic diabetic foot ulcer 2
• Ulcer size: Greater than 1 cm² 1
• Ulcer grade: Typically grade IC or IIC (University of Texas classification) 1
• Failed standard care: Insufficient change in ulcer area after minimum 2 weeks of best standard care with appropriate off-loading 2

Step 2: Exclusions

• Active infection of the wound 2
• Recent surgical revascularization (within 1 month) 1
• Purely neuropathic ulcers without ischemic component (evidence is specific to neuro-ischemic ulcers) 2, 1

Step 3: Application Protocol

• Apply sucrose-octasulfate dressing as adjunctive treatment in addition to continued best standard care 2
• Continue appropriate off-loading throughout treatment 2
• Maintain sharp debridement as clinically indicated 5
• Change dressing frequency based on wound exudate level and clinical condition 1
• Continue treatment for up to 20 weeks or until wound closure 1

Step 4: Monitoring

• Assess wound at 2 weeks after initiation, then monthly 1
• Monitor for wound closure, percentage area reduction, and any adverse events 1
• Most common adverse events are wound infections (20% in treatment group vs 28% in control group in EXPLORER trial) 1

Important Caveats and Pitfalls

Strength of Recommendation Limitations

Despite high-quality data from the EXPLORER trial, the IWGDF guideline provides only a conditional recommendation because this is the only study of this intervention, and the optimal timing of initiating treatment remains to be established. 2

What NOT to Use Instead

The same 2024 IWGDF guidelines provide strong recommendations against several other dressing types for diabetic foot ulcers:

• Do not use collagen or alginate dressings (Strong recommendation; Low evidence) - 9 of 12 studies showed no difference in wound healing 2
• Do not use topical antiseptic or antimicrobial dressings for wound healing (Strong; Moderate) 2
• Do not use honey or bee-related products (Strong; Low) 2
• Do not use topical phenytoin (Strong; Low) 2
• Do not use herbal remedies (Strong; Low) 2

Cost-Effectiveness Considerations

Resource use for sucrose-octasulfate is considered low to moderate, and cost-effectiveness modeling studies from various Western healthcare systems are supportive of its use. 2

Comparison to Other Hydrogels

A 2011 Cochrane review found that basic hydrogel dressings (without sucrose-octasulfate) showed some benefit over basic wound contact dressings (RR 1.80,95% CI 1.27-2.56), but this evidence was of uncertain quality due to risk of bias. 6 The sucrose-octasulfate formulation represents a more advanced hydrogel with stronger evidence specifically for neuro-ischemic ulcers. 1, 3

Equity and Feasibility

The intervention is considered feasible and acceptable to patients in all healthcare settings, with equity unlikely to be reduced. 2