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
Notice bibliographique
Résumé
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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Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,004 | 0,004 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,001 |
| Méta-épidémiologie (sens large) | 0,005 | 0,003 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,002 |
| Communication savante | 0,002 | 0,001 |
| Science ouverte | 0,002 | 0,001 |
| Intégrité de la recherche | 0,003 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,006 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».