Comparative Efficacy of High Purity Type I Collagen-Based Skin Substitute and Dehydrated Human Amnion/Chorion Membrane in Diabetic Foot Ulcers: A Multicentre Randomized Controlled Trial
Bibliographic record
Abstract
BACKGROUND: Diabetic foot ulcers (DFUs) are a major healthcare challenge due to their chronic nature, high recurrence rate, and the substantial morbidity they impose. Effective treatment remains limited, which underscores the need for advanced wound care approaches. High-purity type-I collagen-based skin substitute (HPTC), e.g., Helicoll®, and dehydrated human amnion/chorion membrane (dHACM) are advanced wound therapies with promising results in previous single-centre studies. This multicentre randomized controlled trial compared the efficacy of HPTC versus dHACM added to standard of care (SOC) in treating chronic DFUs. METHODS: A total of 120 patients with DFUs were enrolled across four medical centres in the state of Karnataka, India, and randomized to receive either HPTC (n=60) or dHACM (n=60) along with standard care. The primary outcome was the proportion achieving wound size reduction at four weeks of intervention and one week follow-up, with continuous wound-area monitoring during the treatment window. Secondary outcomes included histological assessment of vascular incursion and wound biology on day 5 (biopsy), time to complete wound closure, percent area reduction over time, number of repeat HPTC applications, adverse events/complications, patient-reported quality of life (QoL), and scar quality (Vancouver Scar Scale (VSS)). Statistical analyses used chi-square or Fisher's exact tests for categorical comparisons, t-tests/Mann-Whitney for continuous/ordinal outcomes, and two-sided alpha. RESULTS: HPTC demonstrated superior healing outcomes with a mean wound area reduction at five weeks, 81.5% ± 12.3 against 64.2% ± 14.1 in the dHACM group (p<0.001). Also, 88.3% (53 patients) of patients in the HPTC group achieved ≥50% wound reduction versus 55% (33 patients) in the dHACM group (p<0.001). Complete wound closure was achieved in 50 (83.3%) HPTC patients compared to 31 (51.7%) dHACM patients (p<0.001). Histological analysis revealed significantly enhanced vascular infiltration (2.4±0.6 vs 1.8±0.7, p<0.001), neo-epithelialization (2.6±0.5 vs 2.1±0.6, p<0.001), fibroblast activity (2.5±0.6 vs 1.9±0.7, p<0.001) and capillary density (45.6 ± 7.9 vs 29.4 ± 9.2 vessels/mm², p<0.001), in the HPTC group. Mean time to closure was 22.2 ± 5.4 days for HPTC versus 28.8±6.2 days for dHACM (p<0.001). Adverse incidence rates were low and similar between arms (HPTC - 6.7% vs dHACM 18.3%, with p = 0.095). Patient-reported QoL improved more in HPTC, especially with respect to resumption of daily activities and social functioning (p<0.001). Mean VSS scores at five weeks were better (lower) in HPTC (4.2±2.1) vs dHACM (6.8±2.8), p<0.001). CONCLUSIONS: In this multicentre study based on a pooled design, HPTC (Helicoll) demonstrated statistically and clinically significant superiority versus dHACM over a four-week treatment period with one-week follow-up for DFUs in terms of percent area reduction, with enhanced cellular activity, faster healing times, and improved patient quality of life. The superior healing effect of Helicoll is attributed to its high-purity type I collagen composition, providing an optimal scaffold for cellular attachment and tissue regeneration. These results align with our prior single-centre experience with Helicoll, demonstrating faster and more complete healing of DFUs compared to dHACM, showing its potential as a more effective treatment option.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".