A randomized controlled trial found that ovine forestomach matrix combined with hyaluronic acid increased wound closure rates in diabetic foot ulcers from 24% to 46% over 12 weeks when added to standard care, though the study had notable limitations that warrant cautious interpretation.
Diabetic foot ulcers represent one of the most serious complications of diabetes, often leading to amputation, reduced mobility, and substantial quality of life decline. When these wounds don't respond to standard care, clinicians turn to advanced therapies known as Cellular, Acellular, and Matrix-like Products (CAMPs). A new entry to this category combines ovine (sheep) forestomach matrix with high molecular weight hyaluronic acid, creating what researchers termed OFM-HA. This trial tested whether adding this composite to standard of care could improve healing outcomes in a population of diabetic patients with full-thickness foot wounds.
The study randomized 143 participants across multiple centers to receive either OFM-HA plus standard care or standard care alone. The primary outcome was straightforward: how many wounds closed completely within 12 weeks. The results showed a meaningful difference. In the OFM-HA plus standard care group, 46% of wounds (31 of 68 participants) achieved complete closure by 12 weeks, compared to 24% (17 of 72 participants) in the standard care-only group. This absolute difference of 22 percentage points translated to a statistically significant p-value of 0.008. When researchers examined healing timelines using Kaplan-Meier survival analysis (which tracks how quickly wounds closed over the entire 12-week period), the OFM-HA group again showed faster overall healing patterns (log-rank p = 0.023). Secondary outcomes including pain reduction and quality of life improvements favored the intervention group, and no unexpected safety signals emerged.
However, several interpretive caveats deserve emphasis. The abstract explicitly flags that the study experienced post-randomization exclusions and differential withdrawal between groups, meaning some participants assigned to one arm dropped out or were excluded at higher rates than others. More critically, when researchers adjusted their analysis to account for these statistical complications, the primary endpoint p-value rose to 0.045, placing it just at the conventional significance threshold. In medical research, a p-value of 0.045 versus 0.008 represents a material difference in confidence: the adjusted analysis suggests a more modest signal than the primary reported result. The study population was also highly selected (participants had to meet specific eligibility criteria), limiting how well results may generalize to all diabetic patients with foot ulcers.
The biological rationale for combining ovine forestomach matrix with hyaluronic acid rests on complementary mechanisms. The forestomach matrix provides a three-dimensional scaffold that can support cellular migration and tissue remodeling, while hyaluronic acid is a naturally occurring polysaccharide in skin that modulates inflammation and promotes hydration in the wound microenvironment. In theory, this pairing creates a composite that addresses multiple phases of wound healing simultaneously. Whether this specific combination offers advantages over other matrix products remains unclear from this single trial.
If you have a diabetic foot ulcer that hasn't responded to standard wound care after several weeks, this trial suggests a composite matrix product may warrant discussion with your wound care specialist. The 46% healing rate over 12 weeks is substantially higher than the 24% seen with standard care alone, representing a clinically meaningful improvement for a population at high risk of serious complications including infection and amputation.
That said, the study's limitations merit honest appraisal. The adjusted analysis confidence was lower than initially reported, the population was carefully selected, and we don't yet know how this product compares to other advanced wound therapies. This should be positioned as promising evidence rather than definitive proof of superiority. Your specific wound characteristics, overall diabetes control, infection status, vascular supply, and access to specialized wound care all influence whether a matrix product is appropriate for you.
Standard diabetic foot ulcer prevention and management fundamentals remain foundational regardless of advanced therapies: tight glycemic control, proper foot inspection, pressure offloading, infection management, and adequate nutrition. Consider discussing high-fiber diet and protein-at-every-meal with your care team, as healing is metabolically demanding. If this product becomes an option for you, ensure close follow-up to assess response, since failure to progress after 4-6 weeks may signal need for alternative approaches.
| Parameter | Value |
|---|---|
| Study Type | Randomized controlled trial |
| Sample Size | 143 participants randomized; 140 in modified intent-to-treat population |
| Intervention | Ovine forestomach matrix plus hyaluronic acid (OFM-HA) plus standard care |
| Control | Standard care alone |
| Primary Outcome | Proportion of wounds healed by 12 weeks |
| Primary Result | 46% (31/68) OFM-HA vs 24% (17/72) control; p = 0.008 (adjusted p = 0.045) |
| Secondary Outcomes | Healing time, percent area reduction, pain, quality of life, safety |
| Duration | 12 weeks |
| Journal | International Wound Journal |
| Year | 2024 |
| Key Limitation | Post-randomization exclusions, differential withdrawal, narrow margin on adjusted analysis |
Banerjee S, et al. A composite ovine forestomach matrix and hyaluronic acid CAMP for the treatment of full thickness wounds of the foot in people with diabetes: A randomized controlled trial. *Int Wound J*. 2024. PubMed. https://pubmed.ncbi.nlm.nih.gov/42823610/
ProtocolEngine provides general health information based on published research. This is not medical advice. Consult a healthcare professional before starting any supplement or health protocol.